(140 days)
No
The document describes a physical medical device (a catheter system) and its intended use for accessing the peripheral vascular system. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The focus is on the physical characteristics and function of the catheter.
No
The device is described as permitting access for purposes such as sampling blood, administering fluids, and monitoring blood pressure, which are diagnostic and procedural access functions, not direct therapeutic interventions.
No
The device is a catheter system used to access the vascular system for sampling blood, administering fluids, performing injections, and monitoring blood pressure, not to diagnose a condition.
No
The device description clearly describes a physical catheter system, including gauge configurations and usable lengths, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is used to access the patient's peripheral vascular system within the body (in vivo) for purposes like administering fluids, sampling blood directly from the bloodstream, and monitoring blood pressure.
- Intended Use: The intended use clearly describes procedures performed directly on the patient, not on specimens in a lab.
While the device is used to sample blood, the sampling itself is a procedure performed on the patient, and the device's primary function is access to the vascular system, not the analysis of the blood sample once it's collected.
N/A
Intended Use / Indications for Use
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.
The safety feature is intended to minimize the risk of sharps injuries.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.
Product codes
FOZ
Device Description
The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance" Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 8 cm (3.15").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's peripheral vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
hospitals, clinics, and other advanced clinical facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing performed on the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System supports substantial equivalence of the subject devices. The following testing has been completed for the subject devices:
- Surface (Extraneous Mater and Defects & Lubricant)
- Wire Guide Advancement Length
- Catheter MR Compatibility
- Device Center of Gravity
- Latex, DEHP, and BPA Content
- Catheter Body Fluid Visualization
- Inactivated Extension Line Clamp
- Catheter Body Markings
- Peak Removal Force
- Catheter/ Needle Transition Insertion Force
- Needle Support
- Wire Guide Advancement Force
- Blood Flash
- Catheter Insertion tip damage
- Catheter column strength
- Catheter Tensile Force
- Catheter Tensile Elongation
- Catheter Body Kink
- Catheter Body to Juncture Hub Kink
- Gravity Flow Rate
- Repeat Pressure Injection (Flow Rate)
- Static Burst pressure under pressure injection
- Catheter Liquid Leakage
- Catheter Air Leakage
- Extension line Clamp Closure Efficacy
- Blood Draw Rate
- Pumped Flow Rate
- Arterial Blood Pressure Monitoring
- Catheter Body Softening
- Catheter Body Drag Force
- Particulate
- Needle Support
- Needle Strength of Union
- Clamp Force
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2024
Arrow International, LLC (A Subsidiary of Teleflex, Inc.) Kim Pennington Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K242281
Trade/Device Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: November 22, 2024 Received: November 22, 2024
Dear Kim Pennington:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Porsche Bennett
Porsche Bennett, For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242281
Device Name
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System
Indications for Use (Describe)
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.
The safety feature is intended to minimize the risk of sharps injuries.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY- K242281
1. Submitter Information
| Name: | Arrow International, LLC (a subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 3015 Carrington Mill Blvd |
| Morrisville, NC 27560 | |
| Telephone Number: | (610) 451-3095 |
| Contact Person: | Kim Pennington |
| Sr. Regulatory Affairs Specialist | |
| Email: | kim.pennington@teleflex.com |
| Date Prepared: | December 20, 2024 |
2. Device Name
Device Trade Name: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200)
3. Predicate Device
K163513: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200)
4. Device Description
The subject device, Arrow™ Endurance™ Extended Dwell Peripheral Catheter System, is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The Endurance catheter is intended to permit access to the patient's peripheral vascular system for short-term venous use to sample blood, administer fluids and for high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance" Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term arterial use to monitor arterial blood pressure and blood sampling. The safety feature is intended to minimize the risk of sharps injuries.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 and 22 gauge configurations with usable lengths of 6 cm (2.36'') and 8 cm (3.15").
5. Intended Use
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is intended to access to the patient's peripheral vascular system for short-term venous or short-term arterial use.
5
6. Indications for Use
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.
The safety feature is intended to minimize the risk of sharps injuries.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.
7. Technological Characteristics
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is substantially equivalent to the predicate Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (K163513) in terms of indications for use, intended use, design, functional performance and materials of construction.
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
|---|---|---|---|
| Arrow™ Endurance™ Extended | |||
| Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended | ||
| Dwell Peripheral Catheter System | |||
| (K163513) | |||
| Intended Use | The Arrow™ Endurance™ | ||
| Extended Dwell Peripheral Catheter | |||
| System is intended to access to the | |||
| patient's peripheral vascular system | |||
| for short-term venous or short-term | |||
| arterial use. | The Arrow™ Endurance™ Extended | ||
| Dwell Peripheral Catheter System is | |||
| intended to access to the patient's | |||
| peripheral vascular system for short-term venous or short-term arterial use. | Same | ||
| Indication for | |||
| Use | The Arrow™ Endurance™ | ||
| Extended Dwell Peripheral Catheter | |||
| System permits access to the | |||
| patient's peripheral vascular system for short- | The ARROW Endurance catheter | ||
| system permits access to the patient's | |||
| peripheral vascular system for short- | Different | ||
| The subject device IFU separates | |||
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
| Arrow™ Endurance™ Extended | |||
| Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended | ||
| Dwell Peripheral Catheter System | |||
| (K163513) | |||
| patient's peripheral vascular system | |||
| for short-term venous use (less than | |||
| 30 days) to sample blood, | |||
| administer fluids, administer blood | |||
| and blood products, and for high | |||
| pressure contrast injections at a | |||
| maximum of 325 psi. |
The Arrow™ Endurance™
Extended Dwell Peripheral Catheter
System permits access to the
patient's peripheral vascular system
for short-term use (less than 30
days) to facilitate arterial blood
pressure measurement and blood
sampling.
The safety feature is intended to
minimize the risk of sharps injuries.
The Arrow™ Endurance™
Extended Dwell Peripheral Catheter
may be used for any patient
population with consideration given
to adequacy of anatomy and
appropriateness of the procedure.
The Arrow™ Endurance™
Extended Dwell Peripheral Catheter
may be used in hospitals, clinics,
and other advanced clinical
facilities. | term use (less than 30 days) to sample
blood, monitor blood pressure, or
administer fluids. The catheter may
be used for high pressure injection.
The safety feature is intended to
minimize the risk of sharps injuries. | peripheral vascular system into
Vascular and Arterial usage and
added the patient population and
usage environment. While there is a
difference in granularity, the intended
use and indications for use of the
subject device is similar. The
difference does not raise new or
different questions of safety and
effectiveness. |
| Single Use | Yes | Yes | Same |
| Duration of Use | Less than 30 days | Less than 30 days | Same |
| Insertion | Gain vascular access with needle, | Gain vascular access with needle, | Same |
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
| | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System
(K163513) | |
| Technique | advance guide wire, advance
catheter, remove needle and
guidewire, deploy needle safety | advance guide wire, advance catheter,
remove needle and guidewire, deploy
needle safety | |
| Principle of
Operation | The catheter is a closed fluid path
system that consists of an insertion
platform and a catheter. | The catheter is a closed fluid path
system that consists of an insertion
platform and a catheter. | Same |
| Shelf Life | 6 months | 2 years | Different
Based on business needs and does not
affect substantial equivalence. Bench
testing and labeling support that there
are no new safety or effectiveness
concerns. See Nonclinical Testing. |
| MR Safety | MR Safe (catheter) | MR Safe (catheter) | Same |
| Device Design Feature | | | |
| Device
Components | Includes Guard, Handle, Advancer,
Slider, Needle Supports, Needle
Safety, Extension Line Clamp,
Needle, Guide Wire, Juncture Hub,
Catheter with Extension Line | Includes Guard, Handle, Advancer,
Slider, Needle Supports, Needle
Safety, Extension Line Clamp,
Needle, Guide Wire, Juncture Hub,
Catheter with Extension Line | Same |
| Device Materials | Guard - Polypropylene
Handle - Polycarbonate
Advancer – Polycarbonate
Slider -ABS
Needle Supports - Polycarbonate
Needle Safety - Stainless Steel
Extension Line Clamp - Acetal | Guard - Polypropylene
Handle - Polycarbonate
Advancer – Polycarbonate
Slider -ABS
Needle Supports - Polycarbonate
Needle Safety - Stainless Steel
Extension Line Clamp - Acetal | Different
The catheter body and coating and
Extension Line Clamp materials are
different. Biocompatibility and bench
top testing demonstrate the difference
does not raise new or different
questions of safety and effectiveness. |
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
| | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System
(K163513) | |
| | Needle – Stainless Steel
Guide Wire - Nitinol
Juncture Hub – Polyurethane
Extension Line - Polyurethane
Luer Hub - Polyurethane
Catheter Body– Quadraflex
Polyurethane with Silicone Coating | Needle - Stainless Steel
Guide Wire - Nitinol
Juncture Hub – Polyurethane
Extension Line - Polyurethane
Luer Hub - Polyurethane
Catheter Body - Tecoflex
Polyurethane | |
| Catheter Design
Configuration | The insertion platform consists of
an ergonomically designed
polycarbonate handle, an integral
echogenic needle with openings to
enhance flashback visibility to
confirm placement in the vessel, a
passive needle safety mechanism, a
needle support to aid in insertion,
and a guide wire with a slider
advancer. | The insertion platform consists of an
ergonomically designed polycarbonate
handle, an integral echogenic needle
with openings to enhance flashback
visibility to confirm placement in the
vessel, a passive needle safety
mechanism, a needle support to aid in
insertion, and a guide wire with a
slider advancer. | Same |
| Catheter Body
OD | 20 Ga, 22 Ga | 18 Ga, 20 Ga, 22 Ga | Different
The subject device does not include
18Ga |
| Catheter Body ID | 0.032" (20 Ga)
0.027" (22 Ga) | 0.039" (18 Ga)
0.032" (20 Ga)
0.027" (22 Ga) | Different
The subject device does not include
18Ga |
| Catheter Usable
Length | 6 cm (2.36")
8 cm (3.15") | 6 cm (2.36")
8 cm (3.15") | Same |
| Needle Safety
Feature | Yes | Yes | Same |
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
| | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System
(K163513) | |
| Blood Safety
Feature | Bloodless (seal and extension lines) | Bloodless (seal and extension lines) | Same |
| Pressure
Injection Limits | 325 psi | 325 psi | Same |
| Sidearm Clamp | Pinch | Slide | Different
A different clamp has no impact on
substantial equivalence. Bench
testing supports that there are no new
safety or effectiveness concerns. See
Nonclinical Testing. |
| Juncture Hub
Advancer | Half Circle Suture Wing Posts
Removed Hub Nose Clips | Round Suture Wing Posts
Hub Nose Clips | Different
Juncture hub advancer design
changes have no impact on
substantial equivalence. Bench
testing supports that there are no new
safety or effectiveness concerns. See
Nonclinical Testing. |
| Handle | Lower needle support
No Catheter Release Tab | No Lower Needle Support
Catheter Release Tab | Different
Handle design changes have no
impact on substantial equivalence.
Bench testing supports that there are
no new safety or effectiveness
concerns. See Nonclinical Testing. |
| Catheter Body
Material | Quadraflex Polyurethane | Tecoflex Polyurethane | Different
The difference in the catheter body
material has no impact on the use or
functionality of the subject
Endurance™ Catheter per its
intended use as demonstrated by
bench and biocompatibility testing,
supporting that there are no new
safety or effectiveness concerns. See
Nonclinical Testing. |
| Coating | MDX Silicone | None | Different |
| Features | Subject Device: | Predicate Device | Assessment of Device Differences |
| | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System | Arrow™ Endurance™ Extended
Dwell Peripheral Catheter System
(K163513) | The addition of a coating has no impact on the use or functionality of the subject Endurance™ Catheter per its intended per its intended use as demonstrated by bench and biocompatibility testing, supporting that there are no new safety or effectiveness concerns. See Nonclinical Testing. |
| Sterilization | | | |
| Sterile | Yes | Yes | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Biocompatibility | | | |
| Biocompatibility | Biocompatible materials used
(per ISO 10993-1)
Contact Type: Externally
Communicating, Circulating Blood
Duration: Prolonged (>24 hrs. and 24 hrs. and