(60 days)
The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient's heart. They are available in fixed curve and steerable configurations. The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies. The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle.
The provided document is an FDA 510(k) premarket notification for the Map-it™ Diagnostic Mapping Catheters. The document states that the device is "substantially equivalent" to a legally marketed predicate device (St. Jude Medical Livewire™ Diagnostic Mapping Catheter). This means the FDA determined that the new device is as safe and effective as the predicate device, and thus does not require a new premarket approval (PMA).
Crucially, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way one might expect for a new, de novo device or a clinical AI/ML device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
Here's an breakdown based on your request, highlighting what is and isn't present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document as specific performance metrics and acceptance thresholds. Instead, the performance is implicitly demonstrated by meeting existing standards and test methods as discussed in the "TESTING PERFORMED" section.
The document states:
"The Map-iT™ Diagnostic Mapping Catheters were thoroughly tested based on existing standards and test methods. These tests included visual, dimensional, electrical performance - continuity, leakage impedance, dielectric; mechanical performance - tensile, torque, deflection, shaft buckling, radio-detectability, corrosion; biocompatibility (short term <24 hours, blood contacting) and packaging. Testing demonstrates that the Map-iT™ Diagnostic Mapping Catheters met the specifications and are substantially equivalent to the predicate."
Therefore, the "acceptance criteria" here are implied to be adherence to the specifications of these standards and methods, and the "reported device performance" is that it "met the specifications."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described is pre-clinical (e.g., electrical, mechanical, biocompatibility) rather than a clinical study with a "test set" in the context of AI/ML or a new clinical performance claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there is no mention of a "test set" requiring expert ground truth in the context of clinical performance evaluation for this device. The testing conducted is primarily engineering and materials-based.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
An MRMC study was not done and is not applicable for this type of device submission. This is a diagnostic mapping catheter, not an AI/ML-assisted diagnostic software requiring human reader performance improvement assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
A standalone performance study of an algorithm was not done and is not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For the engineering and materials performance, the "ground truth" implicitly used would be "specifications" derived from recognized standards and predicate device performance. For biocompatibility, it would be based on laboratory test results showing compliance with established biological safety standards. There is no mention of pathology, outcomes data, or expert consensus in relation to a diagnostic accuracy study for this device.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
Summary of Device Acceptance and Study:
The acceptance of the Map-iT™ Diagnostic Mapping Catheters by the FDA is based on demonstrating substantial equivalence to an existing predicate device (St. Jude Medical Livewire™ Diagnostic Mapping Catheters). The company performed a series of pre-clinical tests (visual, dimensional, electrical, mechanical, radio-detectability, corrosion, and biocompatibility) that confirmed the device "met the specifications" derived from existing standards and the characteristics of the predicate device. The document explicitly states: "There are no new questions raised regarding safety or efficacy of the Map-iT™ Diagnostic Mapping Catheters." This approach is common for 510(k) submissions where a new device is very similar in design, materials, and intended use to a legally marketed device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2016
Access Point Technologies Ep, Inc. % Laurie Lewandowski Consultant Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, Minnesota 55123
Re: K160390
Trade/Device Name: Map-it™ Diagnostic Mapping Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: February 10, 2016 Received: February 11, 2016
Dear Laurie Lewandowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
{1}------------------------------------------------
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mitchell Stein
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160390
Device Name Map-ItTM Diagnostic Mapping Catheters
Indications for Use (Describe)
The APT Map-It™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image is a logo for Access Point Technologies. The logo is blue and features the letters "AP" connected together. Below the letters is the text "Access Point Technologies" in a blue rounded rectangle.
Access Point Technologies 12560 Fletcher Lane Suite 300 Rogers, Minnesota 55374 USA Ph: 763-428-0010 Fax: 763-428-0012
==============================================================================================================================================================================
510(K) SUMMARY
Submitter:
Access Point Technologies EP (APT EP) dba APT Sean Carroll, President 12560 Fletcher Lane Suite 300 Rogers, MN 55374 763-428-0010 Telephone: Fax: 763-428-0012 Email: sean.carroll@apt-inc.us
Primary Contact:
| Laurie Lewandowski | |
|---|---|
| Consultant, Honkanen Consulting | |
| 738 Saddle Wood Drive | |
| Eagan, MN 55123 | |
| Telephone: | 612-770-4038 (cell) |
| Fax: | 763-428-0012 |
| Email: | lalew207@gmail.com |
DATE PREPARED:
April 9, 2016
NAME OF MEDICAL DEVICE:
| Proprietary Name: | Map-iT TM Diagnostic Mapping Catheters |
|---|---|
| Common/Usual Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Electrode Recording Catheter |
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DEVICE CLASSIFICATION:
| Classification Panel: | Cardiovascular |
|---|---|
| Regulatory Class: | II |
| Product Code: | DRF |
| Regulation Number: | 21 CFR 870.1220 |
PREDICATE DEVICES:
| Proprietary Name: | LivewireTM Electrophysiology Catheter |
|---|---|
| Common/Usual Name: | Diagnostic Mapping Catheter |
| Classification Name: | Electrode Recording Catheter |
| 510K Number: | K022380 |
DEVICE DESCRIPTION:
The Map-iTTM Diagnostic Mapping Catheters are biocompatible, flexible, radiopaque fixed and steerable catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, including a guidewire tip configuration to aid the physician in accessing and mapping a patient's heart. They are available in fixed curve and steerable configurations.
The fixed curve catheters are available in 4/3.3F (4F tapering to 3.3F), 4F, 5F and 6F sizes with a 0.026'' floppy guidewire tip configuration in the 4/3.3F and 4F sizes for access into smaller anatomies. The steerable catheters are available in 4F, 5F, 6F and 7F sizes. There is a tip electrode on all models except the guidewire tip and PV loop configuration: the band electrodes are set at predetermined distances along the catheter shaft. The catheters can be used for recording intracardiac signals in the atrial and ventricular regions of the heart and for cardiac stimulation during electrophysiology studies.
The Map-iT™ Diagnostic Mapping Catheters are comprised of a Pebax catheter shaft, platinum-iridium electrodes and electrical connectors that are either shrouded pin for the bipolar configurations or industry standard Redel connectors. The distal end of the fixed catheters is preformed into industry standard shapes with a variety of electrodes spacing to reach specific areas in the targeted chamber of the heart. The steerable catheters are available in a variety of curves that are controlled to the precise location in the heart by pulling or pushing the plunger on the handle. Table 5-1 lists the models and characteristics of the catheters.
{5}------------------------------------------------
INTENDED USE/INDICATION FOR USE:
The APT Map-It ™ Diagnostic Mapping Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
Technologically the Map-iT™ Diagnostic Mapping Catheters are similar to St. Jude Medical Livewire™ Diagnostic Mapping Catheters in terms of indications for use, design, materials, technology and performance. Both families of catheters have shafts comprised of thermoplastic elastomer and platinum-iridium electrodes. Both come in multiple sizes, lengths, preformed curve shapes and configurations, including fixed and steerable, with varying number of electrodes and spacing's that are designed to reach specific areas in the targeted chambers of the heart. The 4/3.3F model functions the same as the predicate devices, with a taper for access. Similarly, the guidewire tip functions identically to a guidewire, providing easier access of the catheter to smaller anatomies.
TESTING PERFORMED
The Map-iT™ Diagnostic Mapping Catheters were thoroughly tested based on existing standards and test methods. These tests included visual, dimensional, electrical performance - continuity, leakage impedance, dielectric; mechanical performance - tensile, torque, deflection, shaft buckling, radio-detectability, corrosion; biocompatibility (short term <24 hours, blood contacting) and packaging. Testing demonstrates that the Map-iT™ Diagnostic Mapping Catheters met the specifications and are substantially equivalent to the predicate.
In addition, the Map-iT™ Diagnostic Mapping Catheters have been on the market in Europe since 2012.
There are no new questions raised regarding safety or efficacy of the Map-iTTM Diagnostic Mapping Catheters.
CONCLUSIONS
The Map-iTM Diagnostic Mapping Catheters are substantially equivalent in design, materials, sterilization, principles of operation, performance and indications for use to current commercially available catheters/cited predicates.
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'able 5-1 Map-iT Diagnostic Mapping Catheter Models and Catheter Characteristics
Fixed Catheters
| Model | French Size | # of Elec | Elec. spacing | Ring Elec Width | Tip Elec Width | Curve | Length |
|---|---|---|---|---|---|---|---|
| 200 | 4/3.3F | 10 | Fixed Curve 4/3.3F Decapolar Catheters2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 75 |
| 201 | 4/3.3F | 10 | 2-10-2-10-2-10-2-10-2 | 1 | 1.6 | S | 75 |
| 202 | 4/3.3F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 |
| 203 | 4/3.3F | 10 | 2-10-2-10-2-10-2-10-2 | 1 | 1.6 | S | 120 |
| 207 | 4/3.3F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 1.6 | S | 75 |
| 209 | 4/3.3F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 1.6 | S | 120 |
| 212 | 4/3.3F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 75 |
| 213 | 4/3.3F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 120 |
| Fixed Curve 4/3.3F Duo-decapolar Catheters | |||||||
| 250 | 4/3.3F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 75 |
| 251 | 4/3.3F | 20 | 2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2 | 1 | 1.6 | S | 75 |
| 252 | 4/3.3F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 |
| 253 | 4/3.3F | 20 | 2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2 | 1 | 1.6 | S | 120 |
| Fixed Curve 4F Bipolar Catheters | |||||||
| 300 | 4F | 2 | 10 | 1 | 1.6 | MPA | 120 |
| 301 | 4F | 2 | 10 | 1 | 1.6 | MPB | 120 |
| Model | FrenchSize | # ofElec | Elec. spacing | RingElecWidth | Tip ElecWidth | Curve | Length |
|---|---|---|---|---|---|---|---|
| 901470 | 4F | 4 | 10-10-10. | 1 | 1.6 | MPA | 120 |
| 901471 | 4F | 4 | 10-10-10. | 1 | 1.6 | MPB | 120 |
| 901472 | 4F | 4 | 10-10-10. | 1 | 1.6 | RVA | 120 |
| 901473 | 4F | 4 | 10-10-10. | 1 | 1.6 | RVB | 120 |
| 901474 | 4F | 4 | 10-10-10. | 1 | 1.6 | HIS | 120 |
| 901475 | 4F | 4 | 10-10-10. | 1 | 1.6 | CS | 120 |
| 901476 | 4F | 4 | 10-10-10. | 1 | 1.6 | CS | 65 |
| 901477 | 4F | 4 | 5-5-5. | 1 | 1.6 | MPA | 120 |
| 901478 | 4F | 4 | 5-5-5. | 1 | 1.6 | MPB | 120 |
| 901479 | 4F | 4 | 5-5-5. | 1 | 1.6 | RVA | 120 |
| 901480 | 4F | 4 | 5-5-5. | 1 | 1.6 | RVB | 120 |
| 901481 | 4F | 4 | 5-5-5. | 1 | 1.6 | HIS | 120 |
| 901482 | 4F | 4 | 2-5-2. | 1 | 1.6 | MPA | 120 |
| 901483 | 4F | 4 | 2-5-2. | 1 | 1.6 | MPB | 65 |
| 901484 | 4F | 4 | 2-5-2. | 1 | 1.6 | MPB | 120 |
| 901485 | 4F | 4 | 2-2-2. | 1 | 1.6 | MPA | 120 |
| 901486 | 4F | 4 | 2-2-2. | 1 | 1.6 | MPB | 120 |
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| Fixed Curve 4F Octapolar Catheters | Fixed Curve 4F Octapolar Catheters | Fixed Curve 4F Duo-decapolar Catheters | |||||
|---|---|---|---|---|---|---|---|
| 901260 | 4F | 8 | 5-5-5-5-5-5-5 | 1 | 1.6 | MPA | 120 |
| 901261 | 4F | 8 | 5-5-5-5-5-5-5 | 1 | 1.6 | MPB | 120 |
| 901262 | 4F | 8 | 5-5-5-5-5-5-5 | 1 | 1.6 | HIS | 120 |
| 901263 | 4F | 8 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | MPA | 120 |
| 901264 | 4F | 8 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | MPB | 120 |
| 901265 | 4F | 8 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | MPB | 120 |
| 901266 | 4F | 8 | 2-2-2-2-2-2-2 | 1 | 1.6 | MPA | 120 |
| 901267 | 4F | 8 | 2-2-2-2-2-2-2 | 1 | 1.6 | MPB | 120 |
| 901268 | 4F | 8 | 2-2-2-2-2-2-2 | 1 | 1.6 | HIS | 120 |
| 901269 | 4F | 8 | 2-10-2-10-2-10-2 | 1 | 1.6 | CS | 120 |
| 901270 | 4F | 8 | 2-10-2-10-2-10-2 | 1 | 1.6 | CS | 65 |
| 901271 | 4F | 8 | 5-5-5-5-5-5-5 | 1 | 1.6 | CS | 120 |
| 901272 | 4F | 8 | 5-5-5-5-5-5-5 | 1 | 1.6 | CS | 65 |
| 901273 | 4F | 8 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | CS | 120 |
| 901274 | 4F | 8 | 2-5-2-5-2-5-2-5-2 | 1 | 1.6 | CS | 65 |
| 901724 | 4F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 75 |
| 901721 | 4F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 75 |
| 901722 | 4F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 120 |
| 901160 | 4F | 6 | 5-5-5-5-5 | 1 | 1.6 MPA 120 |
|---|---|---|---|---|---|
| 901161 | 4F | 6 | 5-5-5-5-5 | 1 | 1.6 MPB 120 |
| 901162 | 4F | 6 | 5-5-5-5-5 | 1 | 1.6 HIS 120 |
| 901163 | 4F | 6 | 2-5-2-5-2 | 1 | 1.6 MPA 120 |
| 901164 | 4F | 6 | 2-5-2-5-2 | 1 | 1.6 MPB 120 |
| 901165 | 4F | 6 | 2-5-2-5-2 | 1 | 1.6 HIS 120 |
| 901166 | 4F | 6 | 2-2-2-2-2 | 1 | 1.6 MPA 120 |
| 901167 | 4F | 6 | 2-2-2-2-2 | 1 | 1.6 MPB 120 |
| 901168 | 4F | 6 | 2-2-2-2-2 | 1 | 1.6 HIS 120 |
| 901169 | 4F | 6 | 5-5-5-175-175 | 1 | 1.6 MPA 120 |
| 901170 | 4F | 6 | 5-5-5-175-175 | 1 | 1.6 MPB 120 |
| 901171 | 4F | 6 | 2-10-2-10-2 | 1 | 1.6 CS 120 |
| 901172 | 4F | 6 | 2-10-2-10-2 | 1 | 1.6 CS 65 |
| 901173 | 4F | 6 | 5-5-5-5-5 | 1 | 1.6 CS 120 |
| 901174 | 4F | 6 | 5-5-5-5-5 | 1 | 1.6 CS 65 |
| 901175 | 4F | 6 | 2-5-2-5-2-5-2 | 1 | 1.6 CS 120 |
| 901176 | 4F | 6 | 2-5-2-5-2-5-2 | 1 | 1.6 CS 65 |
| 901560 | 4F | 10 | 2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 MPA 120 |
| 901561 | 4F | 10 | 2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 MPB 120 |
{8}------------------------------------------------
| Fixed Curve 4F Decapolar Catheters (cont) | Fixed Curve 4F Duo-decapolar Catheters (cont) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4F | 10 | 2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | HIS | 120 | 901723 | 4F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 | ||||||
| 4F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 1.6 | MPA | 120 | Fixed Curve 5F Bipolar Catheters | |||||||||||||
| 4F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 1.6 | MPB | 120 | 901400 | 5F | 2 | 10 | 2 | 2 | MPA | 120 | ||||||
| 4F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 1.6 | HIS | 120 | 901401 | 5F | 2 | 10 | 2 | 2 | MPB | 120 | ||||||
| 4F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 1.6 | CS | 120 | French# ofSize Elec | Elec. spacing | RingElecWidth | Tip ElecWidth | Curve | Length | ||||||||
| Fixed Curve 4F Decapolar Catheters | Fixed Curve 5F Quadripolar Catheters | |||||||||||||||||||
| 4F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 1.6 | CS | 65 | 901421 | 5F | 4 | 2-2-2. | 2 | 2 | MPA | 120 | ||||||
| 4F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 1.6 | CS | 120 | 901422 | 5F | 4 | 2-2-2. | 2 | 2 | MPB | 120 | ||||||
| 4F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 1.6 | CS | 65 | 901423 | 5F | 4 | 10-10-10. | 2 | 2 | CS | 120 | ||||||
| 4F | 10 | 2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | CS | 120 | 901424 | 5F | 4 | 10-10-10. | 2 | 2 | CS | 65 | ||||||
| 4F | 10 | 2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | CS | 65 | 901430 | 5F | 4 | 10-10-10. | 2 | 2 | MPB | 120 | ||||||
| 4F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 1.6 | CS | 120 | 901431 | 5F | 4 | 10-10-10. | 2 | 2 | MPA | 120 | ||||||
| 4F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 1.6 | CS | 65 | 901432 | 5F | 4 | 10-10-10. | 2 | 2 | RVA | 120 | ||||||
| 4F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 75 | 901433 | 5F | 4 | 10-10-10. | 2 | 2 | RVB | 120 | ||||||
| 4F | 10 | 2-10-2-10-2-10-2-10-2 | 1 | 1.6 | S | 75 | 901434 | 5F | 4 | 10-10-10. | 2 | 2 | HIS | 120 | ||||||
| 4F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 | 901435 | 5F | 4 | 5-5-5. | 2 | 2 | MPB | 120 | ||||||
| 4F | 10 | 2-10-2-10-2-10-2-10-2 | 1 | 1.6 | S | 120 | 901436 | 5F | 4 | 5-5-5. | 2 | 2 | MPA | 120 | ||||||
| Fixed Curve 4F Duo-decapolar Catheters | 901437 | 5F | 4 | 5-5-5. | 2 | 2 | RVA | 120 | ||||||||||||
| 4F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 75 | 901438 | 5F | 4 | 5-5-5. | 2 | 2 | RVB | 120 | ||||||
| 4F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 75 | 901439 | 5F | 4 | 5-5-5. | 2 | 2 | HIS | 120 |
{9}------------------------------------------------
| Fixed Curve 4F Duo-decapolar Catheters (cont) | Fixed Curve 5F Quadripolar Catheters (cont) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 120 | 901440 | 5F | 4 | 2-5-2. | 2 | 2 | MPB | 120 |
| 4F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 | 901441 | 5F | 4 | 2-5-2. | 2 | 2 | MPA | 120 |
| Fixed Curve 5F Bipolar Catheters | 901442 | 5F | 4 | 2-5-2. | 2 | 2 | RVA | 120 | ||||||
| 5F | 2 | 10 | 2 | 2 | MPA | 120 | 901443 | 5F | 4 | 2-5-2. | 2 | 2 | RVB | 120 |
| 5F | 2 | 10 | 2 | 2 | MPB | 120 | 901444 | 5F | 4 | 2-5-2. | 2 | 2 | HIS | 120 |
| Fixed Curve 5F Hexapolar Catheters | Fixed Curve 5F Octapolar Catheters | |||||||||||||
| 5F | 6 | 5-5-5-5-5 | 2 | 2 | MPA | 120 | 901200 | 5F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | MPA | 120 |
| 5F | 6 | 5-5-5-5-5 | 2 | 2 | MPB | 120 | 901201 | 5F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | MPB | 120 |
| 5F | 6 | 5-5-5-5-5 | 2 | 2 | HIS | 120 | 901202 | 5F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | HIS | 120 |
| 5F | 6 | 2-5-2-5-2 | 2 | 2 | MPA | 120 | 901203 | 5F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | MPA | 120 |
| 5F | 6 | 2-5-2-5-2 | 2 | 2 | MPB | 120 | 901204 | 5F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | MPB | 120 |
| 5F | 6 | 2-5-2-5-2 | 2 | 2 | HIS | 120 | 901205 | 5F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | HIS | 120 |
| 5F | 6 | 2-2-2-2-2 | 1 | 2 | MPA | 120 | 901206 | 5F | 8 | 2-2-2-2-2-2-2 | 1 | 2 | MPA | 120 |
| 5F | 6 | 2-2-2-2-2 | 1 | 2 | MPB | 120 | 901207 | 5F | 8 | 2-2-2-2-2-2-2 | 1 | 2 | MPB | 120 |
| 5F | 6 | 2-2-2-2-2 | 1 | 2 | HIS | 120 | 901208 | 5F | 8 | 2-2-2-2-2-2-2 | 1 | 2 | HIS | 120 |
| 5F | 6 | 5-5-5-175-175 | 2 | 2 | MPA | 120 | 901209 | 5F | 8 | 2-10-2-10-2-10-2 | 2 | 2 | CS | 120 |
| 5F | 6 | 5-5-5-175-175 | 2 | 2 | MPB | 120 | 901210 | 5F | 8 | 2-10-2-10-2-10-2 | 2 | 2 | CS | 65 |
| 5F | 6 | 2-10-2-10-2 | 2 | 2 | CS | 120 | 901211 | 5F | 8 | 5-5-5-5-5-5-5 | 2 | 2 | CS | 120 |
| 5F | 6 | 2-10-2-10-2 | 2 | 2 | CS | 65 | 901212 | 5F | 8 | 5-5-5-5-5-5-5 | 2 | 2 | CS | 65 |
| 5F | 6 | 5-5-5-5-5 | 2 | 2 | CS | 120 | 901213 | 5F | 8 | 2-5-2-5-2-5-2 | 2 | 2 | CS | 120 |
| 5F | 6 | 5-5-5-5-5 | 2 | 2 | CS | 65 | 901214 | 5F | 8 | 2-5-2-5-2-5-2 | 2 | 2 | CS | 65 |
| 5F | 6 | 2-5-2-5-2 | 2 | 2 | CS | 120 | Fixed Curve 5F Duo-decapolar Catheters | |||||||
| 903150 | 5F | 8 | 2-5-2-5-2-5-2-5-2-5 | 1.6 | S | 120 |
{10}------------------------------------------------
| Fixed Curve 5F Decapolar Catheters | Fixed Curve 5F Duo-decapolar Catheters (cont) | Fixed Curve 6F Bipolar Catheters | Fixed Curve 6F Quadripolar Catheters | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 901518 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPA | 120 | 903451 | 5F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 75 | 903500 | 6F | 2 | 10 | 2 | 2 | MPA | 120 | 901445 | 6F | 4 | 10-10-10. | 2 | 2 | MPB | 120 |
| 901519 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPB | 120 | 903452 | 5F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | 1.6 | S | 120 | 903501 | 6F | 2 | 10 | 2 | 2 | MPB | 120 | 901446 | 6F | 4 | 10-10-10. | 2 | 2 | MPA | 120 |
| 901520 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | HIS | 120 | 903453 | 5F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 | Fixed Curve 6F Quadripolar Catheters | 901447 | 6F | 4 | 10-10-10. | 2 | 2 | RVA | 120 | |||||||
| 903453 | 5F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 1.6 | S | 120 | Fixed Curve 6F Bipolar Catheters | 901448 | 6F | 4 | 10-10-10. | 2 | 2 | RVB | 120 | |||||||||||||||
| 901522 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPB | 120 | 901449 | 6F | 4 | 10-10-10. | 2 | 2 | HIS | 120 | ||||||||||||||||
| 901523 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | HIS | 120 | 901450 | 6F | 4 | 5-5-5. | 2 | 2 | MPB | 120 | ||||||||||||||||
| 901524 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | CS | 120 | 901451 | 6F | 4 | 5-5-5. | 2 | 2 | MPA | 120 | ||||||||||||||||
| 901525 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | CS | 65 | 901452 | 6F | 4 | 5-5-5. | 2 | 2 | RVA | 120 | ||||||||||||||||
| 901526 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | CS | 120 | 901453 | 6F | 4 | 5-5-5. | 2 | 2 | RVB | 120 | ||||||||||||||||
| 901527 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | CS | 65 | 901454 | 6F | 4 | 5-5-5. | 2 | 2 | HIS | 120 | ||||||||||||||||
| 901528 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | CS | 120 | 901455 | 6F | 4 | 2-5-2. | 2 | 2 | MPB | 120 | ||||||||||||||||
| 901529 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | CS | 65 | 901456 | 6F | 4 | 2-5-2. | 2 | 2 | MPA | 120 | ||||||||||||||||
| 901530 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | CS | 120 | 901457 | 6F | 4 | 2-5-2. | 2 | 2 | RVA | 120 | ||||||||||||||||
| 901531 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | CS | 65 | 901458 | 6F | 4 | 2-5-2. | 2 | 2 | RVB | 120 | ||||||||||||||||
| 901578 | 5F | 10 | 4-4-4-29-3-3-3-3-3 | 1 | 2 | MPA | 120 | 901459 | 6F | 4 | 2-5-2. | 2 | 2 | HIS | 120 | ||||||||||||||||
| 901579 | 5F | 10 | 4-4-4-23-4-4-4-4-4 | 1 | 2 | MPA | 120 | 901460 | 6F | 4 | 2-2-2. | 2 | 2 | MPB | 120 | ||||||||||||||||
| 901580 | 5F | 10 | 4-4-4-29-4-4-4-4-4 | 1 | 2 | MPA | 120 | 901461 | 6F | 4 | 2-2-2. | 2 | 2 | MPA | 120 | ||||||||||||||||
| 901581 | 5F | 10 | 4-4-4-23-5-5-5-5-5 | 1 | 2 | MPA | 120 | 901462 | 6F | 4 | 10-10-10. | 2 | 2 | CS | 120 | ||||||||||||||||
| 901582 | 5F | 10 | 4-4-4-29-5-5-5-5-5 | 1 | 2 | MPA | 120 | 901463 | 6F | 4 | 10-10-10. | 2 | 2 | CS | 65 | ||||||||||||||||
| 901583 | 5F | 10 | 5-5-5-20-3-3-3-3-3 | 1 | 2 | MPA | 120 | ||||||||||||||||||||||||
| 901584 | 5F | 10 | 5-5-5-24-3-3-3-3-3 | 1 | 2 | MPA | 120 | ||||||||||||||||||||||||
| 901585 | 5F | 10 | 5-5-5-20-4-4-4-4-4 | 1 | 2 | MPA | 120 | ||||||||||||||||||||||||
| 901586 | 5F | 10 | 5-5-5-24-4-4-4-4-4 | 1 | 2 | MPA | 120 | ||||||||||||||||||||||||
| 901587 | 5F | 10 | 5-5-5-20-5-5-5-5-5 | 1 | 2 | MPA | 120 | ||||||||||||||||||||||||
| 901588 | 5F | 10 | 5-5-5-24-5-5-5-5-5 | 1 | 2 | MPA | 120 | ||||||||||||||||||||||||
| 901589 | 5F | 10 | 4-4-4-29-3-3-3-3-3 | 1 | 2 | MPA | 120 |
{11}------------------------------------------------
| Fixed Curve 5F Decapolar Catheters (cont) | Fixed Curve 6F Decapolar Catheters | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 901590 | 5F | 10 | 4-4-4-23-4-4-4-4-4 | 1 | 2 | MPB | 120 | 901532 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | CS | 120 | ||
| 901591 | 5F | 10 | 4-4-4-29-4-4-4-4-4 | 1 | 2 | MPB | 120 | 901533 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | CS | 65 | ||
| 901592 | 5F | 10 | 4-4-4-23-5-5-5-5-5 | 1 | 2 | MPB | 120 | 901534 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPA | 120 | ||
| 901593 | 5F | 10 | 4-4-4-29-5-5-5-5-5 | 1 | 2 | MPB | 120 | 901535 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPB | 120 | ||
| 901594 | 5F | 10 | 5-5-5-20-3-3-3-3-3 | 1 | 2 | MPB | 120 | 901536 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | HIS | 120 | ||
| 901595 | 5F | 10 | 5-5-5-24-3-3-3-3-3 | 1 | 2 | MPB | 120 | 901537 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPA | 120 | ||
| 901596 | 5F | 10 | 5-5-5-20-4-4-4-4-4 | 1 | 2 | MPB | 120 | 901538 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPB | 120 | ||
| 901597 | 5F | 10 | 5-5-5-24-4-4-4-4-4 | 1 | 2 | MPB | 120 | 901539 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | HIS | 120 | ||
| 901598 | 5F | 10 | 5-5-5-20-5-5-5-5-5 | 1 | 2 | MPB | 120 | 901540 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | CS | 120 | ||
| 901599 | 5F | 10 | 5-5-5-24-5-5-5-5-5 | 1 | 2 | MPB | 120 | 901541 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | CS | 65 | ||
| Fixed Curve 6F Hexapolar Catheters | |||||||||||||||||
| 901130 | 6F | 6 | 5-5-5-5-5 | 2 | 2 | MPA | 120 | 901542 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | CS | 120 | ||
| 901131 | 6F | 6 | 5-5-5-5-5 | 2 | 2 | MPB | 120 | 901543 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | CS | 65 | ||
| 901132 | 6F | 6 | 5-5-5-5-5 | 2 | 2 | HIS | 120 | 901544 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | CS | 120 | ||
| 901133 | 6F | 6 | 2-5-2-5-2 | 2 | 2 | MPA | 120 | 901545 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | CS | 65 | ||
| 901134 | 6F | 6 | 2-5-2-5-2 | 2 | 2 | MPB | 120 | 901822 | 6F | 10 | 4-4-4-29-3-3-3-3-3 | 1 | 2 | MPA | 120 | ||
| 901135 | 6F | 6 | 2-5-2-5-2 | 2 | 2 | HIS | 120 | 901823 | 6F | 10 | 4-4-4-23-4-4-4-4-4 | 1 | 2 | MPA | 120 | ||
| 901824 | 6F | 10 | 4-4-4-29-4-4-4-4-4 | 1 | 2 | MPA | 120 |
{12}------------------------------------------------
| Fixed Curve 6F Hexapolar Catheters (cont) | ||||||||
|---|---|---|---|---|---|---|---|---|
| 901136 | 6F | 6 | 2-2-2-2-2 | 2 | 2 | MPA | 120 | |
| 901137 | 6F | 6 | 2-2-2-2-2 | 2 | 2 | MPB | 120 | |
| 901138 | 6F | 6 | 2-2-2-2-2 | 2 | 2 | HIS | 120 | |
| 901139 | 6F | 6 | 5-5-5-175-175 | 2 | 2 | MPA | 120 | |
| 901140 | 6F | 6 | 5-5-5-175-175 | 2 | 2 | MPB | 120 | |
| 901141 | 6F | 6 | 2-10-2-10-2 | 2 | 2 | CS | 120 | |
| 901142 | 6F | 6 | 2-10-2-10-2 | 2 | 2 | CS | 65 | |
| 901143 | 6F | 6 | 5-5-5-5-5 | 2 | 2 | CS | 120 | |
| 901144 | 6F | 6 | 5-5-5-5-5 | 2 | 2 | CS | 65 | |
| 901145 | 6F | 6 | 2-5-2-5-2 | 2 | 2 | CS | 120 | |
| 901146 | 6F | 6 | 2-5-2-5-2 | 2 | 2 | CS | 65 | |
| Fixed Curve 6F Octapolar Catheters | ||||||||
| 901230 | 6F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | MPA | 120 | |
| 901231 | 6F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | MPB | 120 | |
| 901232 | 6F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | HIS | 120 | |
| 901233 | 6F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | MPA | 120 | |
| 901234 | 6F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | MPB | 120 | |
| Fixed Curve 6F Decapolar Catheters (cont) | ||||||||
| 901825 | 6F | 10 | 4-4-4-23-5-5-5-5-5 | 1 | 2 | MPA | 120 | |
| 901826 | 6F | 10 | 4-4-4-29-5-5-5-5-5 | 1 | 2 | MPA | 120 | |
| 901827 | 6F | 10 | 5-5-5-20-3-3-3-3-3 | 1 | 2 | MPA | 120 | |
| 901828 | 6F | 10 | 5-5-5-24-3-3-3-3-3 | 1 | 2 | MPA | 120 | |
| 901829 | 6F | 10 | 5-5-5-20-4-4-4-4-4 | 1 | 2 | MPA | 120 | |
| 901830 | 6F | 10 | 5-5-5-24-4-4-4-4-4 | 1 | 2 | MPA | 120 | |
| 901831 | 6F | 10 | 5-5-5-20-5-5-5-5-5 | 1 | 2 | MPA | 120 | |
| 901832 | 6F | 10 | 5-5-5-24-5-5-5-5-5 | 1 | 2 | MPA | 120 | |
| 901833 | 6F | 10 | 4-4-4-29-3-3-3-3-3 | 1 | 2 | MPB | 120 | |
| 901834 | 6F | 10 | 4-4-4-23-4-4-4-4-4 | 1 | 2 | MPB | 120 | |
| 901835 | 6F | 10 | 4-4-4-29-4-4-4-4-4 | 1 | 2 | MPB | 120 | |
| 901836 | 6F | 10 | 4-4-4-23-5-5-5-5-5 | 1 | 2 | MPB | 120 | |
| 901837 | 6F | 10 | 4-4-4-29-5-5-5-5-5 | 1 | 2 | MPB | 120 | |
| 901838 | 6F | 10 | 5-5-5-20-3-3-3-3-3 | 1 | 2 | MPB | 120 | |
| 901839 | 6F | 10 | 5-5-5-24-3-3-3-3-3 | 1 | 2 | MPB | 120 | |
| 901840 | 6F | 10 | 5-5-5-20-4-4-4-4-4 | 1 | 2 | MPB | 120 | |
| 901841 | 6F | 10 | 5-5-5-24-4-4-4-4-4 | 1 | 2 | MPB | 120 | |
| 901842 | 6F | 10 | 5-5-5-20-5-5-5-5-5 | 1 | 2 | MPB | 120 | |
| Fixed Curve 6F Decapolar Catheters (cont) | 901843 | 6F | 10 | 5-5-5-24-5-5-5-5-5 | 1 | 2 | MPB | 120 |
{13}------------------------------------------------
| 65 | 75 | 120 | 120 | 75 | 120 | 75 | 120 |
|---|---|---|---|---|---|---|---|
| S | S | S | S | S | S | S | |
| Guidewire | Guidewire | Guidewire | Guidewire | Guidewire | Guidewire | Guidewire | |
| Fixed Curve 4F Decapolar Catheters with Guidewire Tip | 2-8-2-8-2-8-2-8-2 | 2-8-2-8-2-8-2-8-2 | 2-10-2-10-2-10-2-10-2 | 2-10-2-10-2-10-2-10-2 | Fixed Curve 4F Duo-decapolar Catheters with Guidewire Tip | 2-8-2-8-2-8-2-8-2-8-2-8-2 | 2-8-2-8-2-8-2-8-2-8-2-8-2 |
| 10 | 10 | 10 | 10 | 20 | 20 | ||
| 4F | 4F | 4F | 4F | 4F | 4F | ||
| 903307 | 903308 | 903313 | 903314 | 903351 | 903353 |
| Fixed Curve 6F Octapolar Catheters (cont) | ||||||||
|---|---|---|---|---|---|---|---|---|
| 901235 | 6F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | HIS | 120 | |
| 901236 | 6F | 8 | 2-2-2-2-2-2-2 | 1 | 2 | MPA | 120 | |
| 901237 | 6F | 8 | 2-2-2-2-2-2-2 | 1 | 2 | MPB | 120 | |
| 901238 | 6F | 8 | 2-2-2-2-2-2-2 | 1 | 2 | HIS | 120 | |
| 901239 | 6F | 8 | 2-10-2-10-2-10-2 | 1 | 2 | CS | 120 | |
| 901240 | 6F | 8 | 2-10-2-10-2-10-2 | 1 | 2 | CS | 65 | |
| 901241 | 6F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | CS | 120 | |
| 901242 | 6F | 8 | 5-5-5-5-5-5-5 | 1 | 2 | CS | 65 | |
| 901243 | 6F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | CS | 120 | |
| 901244 | 6F | 8 | 2-5-2-5-2-5-2 | 1 | 2 | CS | 65 | |
| FIXED CURVE CATHETERS WITH GUIDEWIRE TIP | ||||||||
| Fixed Curve 4/3.3F Decapolar Catheters with Guidewire Tip | ||||||||
| 903214 | 4/3.3F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | Guidewire | S | 75 | |
| 903215 | 4/3.3F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | Guidewire | S | 120 | |
| 903217 | 4/3.3F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | Guidewire | S | 120 | |
| 903218 | 4/3.3F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | Guidewire | S | 75 | |
| 903219 | 4/3.3F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | Guidewire | S | 120 | |
| 903220 | 4/3.3F | 10 | 2-10-2-10-2-10-2-10-2 | 1 | Guidewire | S | 75 | |
| 903221 | 4/3.3F | 10 | 2-10-2-10-2-10-2-10-2 | 1 | Guidewire | S | 120 |
{14}------------------------------------------------
| Fixed Curve 4/3.3F Duo-decapolar Catheters with Guidewire Tip | |||||||
|---|---|---|---|---|---|---|---|
| 903254 | 4/3.3F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | Guidewire | S | 75 |
| 903255 | 4/3.3F | 20 | 2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2 | 1 | Guidewire | S | 75 |
| 903256 | 4/3.3F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | Guidewire | S | 120 |
| 903257 | 4/3.3F | 20 | 2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2 | 1 | Guidewire | S | 120 |
| 903270 | 4/3.3F | 20 | 5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5 | 1 | Guidewire | S | 120 |
| 903271 | 4/3.3F | 20 | 5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5 | 1 | Guidewire | S | 120 |
| 903272 | 4/3.3F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | Guidewire | S | 75 |
| 903273 | 4/3.3F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | Guidewire | S | 120 |
{15}------------------------------------------------
| Catheters |
|---|
| Steerable |
| Model | French Size | # of Elec | Elec. spacing | Ring Elec Width | Tip Elec Width | Curve | Length (cm) |
|---|---|---|---|---|---|---|---|
| Steerable 4F Quadripolar Catheters | |||||||
| 903600 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-B | 110 |
| 903601 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-D | 110 |
| 903602 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-DL | 110 |
| 903603 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-B | 110 |
| 903604 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-D | 110 |
| 903605 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-DL | 110 |
| 903606 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-S | 110 |
| 903607 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-S | 110 |
| 903608 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-SL | 110 |
| 903609 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-SL | 110 |
| 903610 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-CS-S | 110 |
| 903611 | 4F | 4 | 2-8-2. | 1 | 2 | MPD-CS-S | 110 |
| 903612 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-CS-S | 110 |
| 903613 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-CS-S | 110 |
| 903614 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-CS-M | 110 |
| 903615 | 4F | 4 | 2-8-2. | 1 | 2 | MPD-CS-M | 110 |
| 903616 | 4F | 4 | 2-2-2. | 1 | 2 | MPD-CS-M | 110 |
| 903617 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-CS-M | 110 |
| 903618 | 4F | 4 | 2-5-2. | 1 | 2 | MPD-CS-M | 110 |
| ofElec | Elec. spacing | RingElecWidth | TipElecWidth | Curve | Length(cm) |
|---|---|---|---|---|---|
| Steerable 4F Pentapolar Catheters | |||||
| 5 | 5-5-5-175 | 1 | 2 | MPD-B | 110 |
| 5 | 5-5-5-175 | 1 | 2 | MPD-D | 110 |
| 5 | 5-5-5-175 | 1 | 2 | MPD-DL | 110 |
| 5 | 2-5-2-175 | 1 | 2 | MPD-B | 110 |
| 5 | 2-5-2-175 | 1 | 2 | MPD-D | 110 |
| 5 | 2-5-2-175 | 1 | 2 | MPD-DL | 110 |
| 5 | 2-2-2-175 | 2 | 2 | MPD-S | 110 |
| 5 | 5-5-5-175 | 2 | 2 | MPD-S | 110 |
| 5 | 2-2-2-175 | 1 | 2 | MPD-SL | 110 |
| 5 | 5-5-5-175 | 1 | 2 | MPD-SL | 110 |
{16}------------------------------------------------
| Steerable 5F Pentapolar Catheters | ||||||||
|---|---|---|---|---|---|---|---|---|
| 110 | 904301 | 5F | 5 | 5-5-5-175 | 1 | 2 | MPD-B | 110 |
| 110 | 904302 | 5F | 5 | 5-5-5-175 | 1 | 2 | MPD-D | 110 |
| 110 | 904303 | 5F | 5 | 5-5-5-175 | 1 | 2 | MPD-DL | 110 |
| 110 | 904304 | 5F | 5 | 2-5-2-175 | 1 | 2 | MPD-B | 110 |
| 110 | 904305 | 5F | 5 | 2-5-2-175 | 1 | 2 | MPD-D | 110 |
| 110 | 904306 | 5F | 5 | 2-5-2-175 | 1 | 2 | MPD-DL | 110 |
| 110 | 904307 | 5F | 5 | 2-2-2-175 | 1 | 2 | MPD-S | 110 |
| 110 | 904308 | 5F | 5 | 5-5-5-175 | 1 | 2 | MPD-S | 110 |
| 110 | 904309 | 5F | 5 | 2-2-2-175 | 1 | 2 | MPD-SL | 110 |
| 110 | 904310 | 5F | 5 | 5-5-5-175 | 1 | 2 | MPD-SL | 110 |
| Steerable 5F Decapolar Catheters | ||||||||
| 110 | 901656 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-S | 110 |
| 110 | 901657 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-S | 110 |
| 110 | 901880 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-S-M | 110 |
| 110 | 901881 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-S-L | 110 |
| 110 | 901882 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-S-M | 110 |
| Steerable 4F Quadripolar Catheters | |||||||
|---|---|---|---|---|---|---|---|
| 903619 | 4F | 4 | 2-8-2. | 1 | 2 | MPD-CS-L | 110 |
| 903620 | 4F | 4 | 2-2-2. | 1 | 2 | MPD-CS-L | 110 |
| 903621 | 4F | 4 | 5-5-5. | 1 | 2 | MPD-CS-L | 110 |
| Steerable 5F Quadripolar Catheters | |||||||
| 901600 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-B | 110 |
| 901601 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-D | 110 |
| 901602 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-B | 110 |
| 901603 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-D | 110 |
| 901700 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-DL | 110 |
| 901701 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-DL | 110 |
| 901698 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-S | 110 |
| 901604 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-S | 110 |
| 901702 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-SL | 110 |
| 901703 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-SL | 110 |
| 903700 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-CS-S | 110 |
| 903701 | 5F | 4 | 2-8-2. | 1 | 2 | MPD-CS-S | 110 |
| 903702 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-CS-S | 110 |
| 903703 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-CS-S | 110 |
| 903704 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-CS-M | 110 |
| 903705 | 5F | 4 | 2-8-2. | 1 | 2 | MPD-CS-M | 110 |
{17}------------------------------------------------
| Catheters (cont) | Steerable 5F Decapolar Catheters (cont) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2 | MPD-CS-M | 110 | 901883 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-S-L | 110 |
| 1 | 2 | MPD-CS-M | 110 | 901884 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-S-M | 110 |
| 1 | 2 | MPD-CS-L | 110 | 901885 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-S-L | 110 |
| 1 | 2 | MPD-CS-L | 110 | 901886 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-S-M | 110 |
| 1 | 2 | MPD-CS-L | 110 | 901887 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-S-L | 110 |
| 1 | 2 | MPD-CS-L | 110 | 901650 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-D | 110 |
| 1 | 2 | MPD-S-M | 110 | 901651 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-D | 110 |
| 1 | 2 | MPD-S-M | 110 | 901652 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-D | 110 |
| 1 | 2 | MPD-S-M | 110 | 901704 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-DL | 110 |
| 1 | 2 | MPD-S-L | 110 | 901705 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-DL | 110 |
| 1 | 2 | MPD-S-L | 110 | 901706 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-DL | 110 |
| 1 | 2 | MPD-S-L | 110 | 901707 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-SL | 110 |
| 901708 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-SL | 110 | ||||
| 1 | 2 | MPD-B | 110 | 903730 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-S | 110 |
| 1 | 2 | MPD-D | 110 | 903731 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-S | 110 |
| 1 | 2 | MPD-B | 110 | 903732 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-CS-S | 110 |
| 1 | 2 | MPD-DI | 110 | 903733 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-S | 110 |
| Steerable 5F Quadripolar Catheters (cont) | |||||||
|---|---|---|---|---|---|---|---|
| 903706 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-CS-M | 110 |
| 903707 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-CS-M | 110 |
| 903708 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-CS-L | 110 |
| 903709 | 5F | 4 | 2-8-2. | 1 | 2 | MPD-CS-L | 110 |
| 903710 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-CS-L | 110 |
| 903711 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-CS-L | 110 |
| 901792 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-S-M | 110 |
| 901793 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-S-M | 110 |
| 901794 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-S-M | 110 |
| 901795 | 5F | 4 | 2-5-2. | 1 | 2 | MPD-S-L | 110 |
| 901796 | 5F | 4 | 5-5-5. | 1 | 2 | MPD-S-L | 110 |
| 901797 | 5F | 4 | 2-2-2. | 1 | 2 | MPD-S-L | 110 |
| Steerable 6F Quadripolar Catheters | |||||||
| 901610 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-B | 110 |
| 901611 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-D | 110 |
| 901612 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-B | 110 |
| 901709 | 6F | 4 | 5-5-5 | 1 | 2 | MPD- | 110 |
5-16
{18}------------------------------------------------
| Steerable 6F Quadripolar Catheters (cont) | Steerable 5F Decapolar Catheters (cont) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 901613 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-D | 110 | 903734 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-M | 110 |
| 901710 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-DL | 110 | 903735 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-M | 110 |
| 901699 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-S | 110 | 903736 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-CS-M | 110 |
| 901614 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-S | 110 | 903737 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-M | 110 |
| 901712 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-SL | 110 | 903738 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-L | 110 |
| 901713 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-SL | 110 | 903739 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-L | 110 |
| 903800 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-CS-S | 110 | 903740 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-CS-L | 110 |
| 903801 | 6F | 4 | 2-8-2. | 1 | 2 | MPD-CS-S | 110 | 903741 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-L | 110 |
| 903802 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-CS-S | 110 | 901653 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-G | 110 |
| 903803 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-CS-S | 110 | 901654 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-G | 110 |
| 903804 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-CS-M | 110 | 901655 | 5F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-G | 110 |
| 903805 | 6F | 4 | 2-8-2. | 1 | 2 | MPD-CS-M | 110 | 901780 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-M2 | 110 |
| 903806 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-CS-M | 110 | 901781 | 5F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-L2 | 110 |
| 903807 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-CS-M | 110 | 901782 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-M2 | 110 |
| 903808 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-CS-L | 110 | 901783 | 5F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-L2 | 110 |
| 903809 | 6F | 4 | 2-8-2. | 1 | 2 | MPD-CS-L | 110 | 901784 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-M2 | 110 |
| 903810 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-CS-L | 110 | 901785 | 5F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-L2 | 110 |
{19}------------------------------------------------
| Steerable 6F Duo-decapolar Catheters | Steerable 7F Quadripolar Catheters | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6F | 20 | 1 | 2 | 7F | 4 | 1 | 2 | ||||||||||
| 901670 | 6F | 20 | 2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2-10-2 | 1 | 2 | MPD-H | 100 | 901620 | 7F | 4 | 2-5-2. | 1 | 2 | MPD-A | 110 | ||
| 901671 | 6F | 20 | 2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-H | 100 | 901621 | 7F | 4 | 2-5-2. | 1 | 2 | MPD-B | 110 | ||
| 901672 | 6F | 20 | 5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-H | 100 | 901622 | 7F | 4 | 2-5-2. | 1 | 2 | MPD-C | 110 | ||
| 901673 | 6F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-H | 100 | 901623 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-D | 110 | ||
| 901674 | 6F | 20 | 2-8-2-8-2-8-2-8-2-60-2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-H | 100 | 901626 | 7F | 4 | 2-5-2. | 1 | 2 | MPD-B | 85 | ||
| 901675 | 6F | 20 | 2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-L | 100 | 901627 | 7F | 4 | 2-5-2. | 1 | 2 | MPD-C | 85 | ||
| 901719 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-DL | 110 | ||||||||||
| 901624 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-E | 110 | ||||||||||
| 901625 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-F | 110 |
| Steerable 6F Quadripolar Catheters (cont) | Steerable 6F Pentapolar Catheters | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 903811 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-CS-L | 904351 | 6F | 5 | 5-5-5-175 | 1 | 2 | MPD-B | 904357 | 5F | 5 | 2-2-2-175 | 110 | |
| 901798 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-S-M | 904352 | 6F | 5 | 5-5-5-175 | 1 | 2 | MPD-D | 904358 | 5F | 5 | 5-5-5-175 | 110 | |
| 901799 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-S-M | 904353 | 6F | 5 | 5-5-5-175 | 1 | 2 | MPD-DL | 904359 | 6F | 5 | 2-2-2-175 | 110 | |
| 901876 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-S-M | 904354 | 6F | 5 | 2-5-2-175 | 1 | 2 | MPD-B | 904360 | 6F | 5 | 5-5-5-175 | 110 | |
| 901877 | 6F | 4 | 2-5-2. | 1 | 2 | MPD-S-L | 904355 | 6F | 5 | 2-5-2-175 | 1 | 2 | MPD-D | ||||||
| 901878 | 6F | 4 | 5-5-5. | 1 | 2 | MPD-S-L | 904356 | 6F | 5 | 2-5-2-175 | 1 | 2 | MPD-DL | ||||||
| 901879 | 6F | 4 | 2-2-2. | 1 | 2 | MPD-S-L |
{20}------------------------------------------------
| Steerable 7F Quadripolar Catheters (cont) | ||||||||
|---|---|---|---|---|---|---|---|---|
| 901720 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-DL | 85 | |
| 901629 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-E | 85 | |
| 901630 | 7F | 4 | 2-5-2. | 1 | 4 | MPD-F | 85 | |
| Steerable 7F Decapolar Catheters | ||||||||
| 903900 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-D | 110 | |
| 903901 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-D | 110 | |
| 903902 | 7F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-D | 110 | |
| 903903 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-DL | 110 | |
| 903904 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-DL | 110 | |
| 903905 | 7F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-DL | 110 | |
| 903906 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-G | 110 | |
| 903907 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-G | 110 | |
| 903908 | 7F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-G | 110 | |
| 903909 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-S | 110 | |
| 903910 | 7F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-S | 110 | |
| 903911 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-SL | 110 | |
| 903912 | 7F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-SL | 110 | |
| 903913 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-S | 110 |
| Steerable 6F Decapolar Catheters | |||||||
|---|---|---|---|---|---|---|---|
| 901888 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-S-M | 110 |
| 901889 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-S-L | 110 |
| 901890 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-S-M | 110 |
| 901891 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-S-L | 110 |
| 901892 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-S-M | 110 |
| 901893 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-S-L | 110 |
| 901894 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-S-M | 110 |
| 901895 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-S-L | 110 |
| 901660 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-D | 110 |
| 901661 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-D | 110 |
| 901662 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-D | 110 |
| 901714 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-DL | 110 |
| 901715 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-DL | 110 |
| 901716 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-DL | 110 |
| 901717 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-SL | 110 |
| 901718 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-SL | 110 |
| 903830 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-S | 110 |
{21}------------------------------------------------
| Steerable 7F Decapolar Catheters (cont) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| MPD-CS-S | 110 | 903914 | 7F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-S | 110 | ||
| MPD-CS-S | 110 | 903915 | 7F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-CS-S | 110 | ||
| MPD-CS-S | 110 | 903916 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-S | 110 | ||
| MPD-CS-M | 110 | 903917 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-M | 110 | ||
| MPD-CS-M | 110 | 903918 | 7F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-M | 110 | ||
| MPD-CS-M | 110 | 903919 | 7F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-CS-M | 110 | ||
| MPD-CS-M | 110 | 903921 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-M | 110 | ||
| MPD-CS-L | 110 | 903922 | 7F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | MPD-CS-L | 110 | ||
| MPD-CS-L | 110 | 903923 | 7F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | MPD-CS-L | 110 | ||
| MPD-CS-L | 110 | 903924 | 7F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | MPD-CS-L | 110 | ||
| MPD-CS-L | 110 | 903925 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | MPD-CS-L | 110 | ||
| MPD-G | 110 | Steerable 7F Decapolar PV Catheters | |||||||||
| MPD-G | 110 | 901641 | 7F | 10 | 3-3-3-3-3-3-3-3-3 | 1 | PV12 | 110 | |||
| MPD-G | 110 | 901642 | 7F | 10 | 4-4-4-4-4-4-4-4-4 | 1 | PV15 | 110 | |||
| MPD-S | 110 | 901643 | 7F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | PV18 | 110 | |||
| MPD-S | 110 | 901644 | 7F | 10 | 6-6-6-6-6-6-6-6-6 | 1 | PV21 | 110 | |||
| MPD-CS-M2 | 110 | 901645 | 7F | 10 | 7-7-7-7-7-7-7-7-7 | 1 | PV24 | 110 |
| 903831 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | 110 | MPD-CS-S | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 903833 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | 110 | MPD-CS-S | ||||||||||
| 903834 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | 110 | MPD-CS-S | ||||||||||
| 903835 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | 110 | MPD-CS-M | ||||||||||
| 903836 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | 110 | MPD-CS-M | ||||||||||
| 903837 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | 110 | MPD-CS-M | ||||||||||
| 903838 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | 110 | MPD-CS-M | ||||||||||
| 903839 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | 110 | MPD-CS-L | ||||||||||
| 903840 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | 110 | MPD-CS-L | ||||||||||
| 903841 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | 110 | MPD-CS-L | ||||||||||
| 903842 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | 110 | MPD-CS-L | ||||||||||
| 901663 | 6F | 10 | 5-5-5-5-5-5-5-5-5 | 1 | 2 | 110 | MPD-G | ||||||||||
| 901664 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | 110 | MPD-G | ||||||||||
| 901665 | 6F | 10 | 2-2-2-2-2-2-2-2-2 | 1 | 2 | 110 | MPD-G | ||||||||||
| 901666 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | 110 | MPD-S | ||||||||||
| 901667 | 6F | 10 | 2-8-2-8-2-8-2-8-2 | 1 | 2 | 110 | MPD-S | ||||||||||
| 901786 | 6F | 10 | 2-5-2-5-2-5-2-5-2 | 1 | 2 | 110 | MPD-CS-M2 | ||||||||||
| Steerable 6F Decapolar Catheters (cont) |
{22}------------------------------------------------
| Steerable 7F Duo-decapolar PV Catheters | |||||||
|---|---|---|---|---|---|---|---|
| 903950 | 7F | 20 | 3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3-3 | 0.6 | - | PV12 | 110 |
| 903951 | 7F | 20 | 4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4 | 0.6 | - | PV15 | 110 |
| 903952 | 7F | 20 | 5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5-5 | 0.6 | - | PV18 | 110 |
| 903953 | 7F | 20 | 6-6-6-6-6-6-6-6-6-6-6-6-6-6-6-6-6-6-6 | 0.6 | - | PV21 | 110 |
| 903954 | 7F | 20 | 7-7-7-7-7-7-7-7-7-7-7-7-7-7-7-7-7-7-7 | 0.6 | - | PV24 | 110 |
| 110 | 110 | 110 | 110 | 110 | 100 | 1 00 | 00 I | 100 | 100 | 100 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TIS Cam | ות מנויות מנוא | נתנוי | MPD- CS-M2 | כתבים במש | MPD-H | MPD-H | MPD-F | MPD-H | MPD-H | MPD- | ||
| ਟ | ਟ | ਟ | ರ | ਟ | ਟ | ਟ | ਟ | ਟ | ਟ | ਟ | ||
| I | I | I | I | I | I | I | I | I | I | I | ||
| teerable 6F Decapolar Catheters (con | 5-2-5-2-5-2-5 | 8-2-8-2-8-2- | 8-2-8-2-8-2 | 5-5-5-5-5-5 | 5-5-5-5-5-5-5 | eerable 7F Duo-decapolar Catheter | 10-2-10-2-10-2-10-2 0-2-10-2-10-2-10-2 0-2-10-2-10-2-10-2 | 5-2-5-2-5-2-5-2-5-2- 5-2-5-2-5-2-5-2- 2-5-2-5-2 | 5-5-5-5-5-5-5-5-5-5 5-5-5-5-5-5-5-5- 5-5-5-5-5 | 8-2-8-2-8-2-8-2-1 8-2-8-2-8-2-8-2-1 2-8-2-8-2 | 8-2-8-2-8-2-8-2- 60-2-8-2-8-2-8-2 2-8-2-8-2 | 8-2-8-2-8-2-8-2 8-2-8-2-8-2-8-2 2-8-2-8-2 |
| 01 | 01 | 01 | 01 | 01 | 07 | 00 | 00 | 07 | 00 | 00 | ||
| 19 | 19 | 19 | 19 | 19 | EL | EL | EL | EL | LE | EL | ||
| 01787 | 901788 | 901789 | 901790 | 90179 | 0168( | 90168 | 901682 | 901683 | 901684 | 901685 |
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).