(100 days)
Not Found
No
The device description and summary of performance studies do not mention any AI or ML capabilities. The device is a physical catheter for guiding other devices.
No
The device is a guiding catheter used to introduce other interventional/diagnostic devices, not to provide therapy itself.
No
Explanation: The device is described as a catheter intended for the "intravascular introduction of interventional/diagnostic devices," but it is not itself described as diagnosing a condition. It facilitates the use of other diagnostic devices.
No
The device description clearly describes a physical catheter with various material properties, coatings, and a luer fitting, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intravascular introduction of interventional/diagnostic devices" within the body (peripheral, coronary, and neurovasculature). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a catheter designed for navigating blood vessels and facilitating the passage of other devices inside the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to detect diseases, conditions, or infections.
This device is a medical device used within the body for interventional and diagnostic procedures, not a test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The ENVOY Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The catheter has an outer hydrophilic coating on the outer surface that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the distal tip is clearly distinguished by a radiopaque marker band which is approximately 3mm from the distal tip. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The proposed ENVOY® Distal Access (DA) Guiding Catheter has the same intended use, sterilization process, function, mechanism of action, and clinical utility as the predicate ENVOY® Distal Access (DA) Guiding Catheter, and is similar in regards to design, material, and manufacturing. The proposed ENVOY DA was shown to be substantially equivalent to the predicate device through comparison of indications for use, function, operating principle, bench testing, biocompatibility, and materials.
Bench Testing:
Results of verification and validation testing that was conducted on the proposed ENVOY® Distal Access (DA) Guiding Catheter demonstrates that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new questions of safety and effectiveness. Appropriate testing was identified based on a review of the products' risk analyses and previous validation and verification testing.
The following Verification and Validation tests were conducted to verify the modified design ENVOY® Distal Access (DA) Guiding Catheter:
- Visual Inspection
- Catheter Shape
- Catheter Dimensional Verification
- Tensile Strength Testing
- Hydrophilic Coating Integrity
- System Liquid Leakage Testing
- Delamination of PTFE Liner Testing
- Lateral Stiffness Testing
- Linear Stiffness Testing
- Back-Up Support
- Track Testing
- Sheath Introducer Compatibility
- Hub Luer Taper
- System Air Leakage
- Shaft Peel Strength
The following Packaging Validation Testing was conducted with the proposed ENVOY® Distal Access (DA) Guiding Catheter:
- Visual Inspection
- Dve Leak
- Seal Strength
The following Biocompatibility Testing was conducted with the proposed ENVOY® Distal Access (DA) Guiding Catheter:
- In Vitro Cytotoxicity – MEM Elution
- Sensitization Guinea Pig Maximization
- Intracutaneous/Irritation Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Genotoxicity
- In Vitro Bacterial Mutagenicity Ames Assay
- In Vitro Mouse Lymphoma Assay with extended treatment
- In Vivo Mouse Micronucleus Assay
- Hemocompatibility
- In Vitro Hemolysis Direct & Extract Method
- Partial Thromboplastin Time (PTT)
- Complement Activation C3a & SC5b-9 Assay
- In Vivo Thrombogenicity
- Physicochemical Aqueous Extraction Tests
In addition, the new sterile pouch packaging material was evaluated for in vitro cytotoxicity and was tested per ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.
The following Sterilization Test was conducted with the ENVOY® Distal Access (DA) Guiding Catheter:
- USP Limumus Amebocyte Lysate (LAL) Test - Kinetic Chromogenic Method
Animal Testing:
No animal studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical Testing:
No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Conclusion:
Based upon the design, materials, function, intended use, and the non-clinical testing performed by Codman it is concluded that the proposed ENVOY® Distal Access (DA) Guiding Catheter is substantially equivalent to the current ENVOY® Distal Access (DA) Guiding Catheter (K120229), and therefore, does not raise any new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
SECTION 005 510(k) Summary [As Required By 21 CFR 807.92(a)]
. APR 2 4 2014
| A. Sponsor | |
|---|---|
| Submitter's Name: Codman & Shurtleff, Inc. | |
| Address: 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Primary Contact: | Hannah Foley |
| Telephone: | (305) 265-6810 |
| Fax: | (508) 977-6979 |
| Secondary Contact: | Amarilys Machado |
|---|---|
| Telephone: | (305) 265-6869 |
| Fax: | (508) 977-6979 |
- B. Date Prepared: January 10, 2014
C. Device Name and Classification:
| Proprietary Name: | ENVOY® Distal Access (DA) Guiding Catheter |
|---|---|
| Common/Usual Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250), Class II |
| Product Code: | DQY |
D. Predicate Devices
This 510(k) submission provides pre-market notification for the ENVOY® Distal Access (DA) Guiding Catheter line extension and modifications. The proposed line extension and modifications have not altered the fundamental technology of the predicate devices or the devices' intended use.
| Table 1: Prior 510(k) Clearances | |||||
|---|---|---|---|---|---|
| 510(k) | |||||
| Number | Date Cleared | Name | Manufacturer | Product Code | Predicate For: |
| Predicate | |||||
| K120229 | 02/24/2012 | ENVOY® Distal Access | |||
| Guiding Catheter | Codman & | ||||
| Shurtleff, Inc. | DQY | Intended Use Design | |||
| Materials | |||||
| Manufacturing | |||||
| Sterilization | |||||
| Predicate | |||||
| K093184 | 11/06/2009 | ENVOY Guiding Catheters | Codman & | ||
| Shurtleff. Inc. | DQY | Packaging |
1
E. Device Description
The ENVOY Distal Access (DA) Guiding Catheter is a variable stiffness, braided catheter with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The distal segment is flexible for navigation into distal vasculature. The catheter has an outer hydrophilic coating on the outer surface that reduces friction during manipulation in the vessel. The lubricious PTFE lined inner lumen is designed to facilitate movement of the guide wires and other devices. A luer fitting located on the end of the catheter hub can be used to attach accessories. The distal section of the catheter is radiopaque to aid visualization under fluoroscopy, and the distal tip is clearly distinguished by a radiopaque marker band which is approximately 3mm from the distal tip. The catheter is available with preshaped tips to facilitate positioning. A peel away introducer is included to facilitate insertion into the sheath.
F. Indications for Use
The ENVOY Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
G. Summary of Technological Characteristics of the Proposed Device to the Predicate Device
The proposed ENVOY® Distal Access (DA) Guiding Catheter is substantially equivalent to the predicate ENVOY® Distal Access (DA) Guiding Catheter. No new technological characteristics are being introduced with the proposed device.
The proposed ENVOY® Distal Access (DA) Guiding Catheter has the same intended use, sterilization process, function, mechanism of action, and clinical utility as the predicate ENVOY® Distal Access (DA) Guiding Catheter, and is similar in regards to design, material, and manufacturing. The proposed ENVOY DA was shown to be substantially equivalent to the predicate device through comparison of indications for use, function, operating principle, bench testing, biocompatibility, and materials. A summary table including characteristics of the proposed device compared with those of the predicate device is provided in Table 2A and 2B.
2
1
| Description | Predicate Device:
ENVOY® DA Guiding Catheter
(K120229) | This Submission:
ENVOY® DA Guiding Catheter |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Envoy Distal Access Guiding Catheter is
intended for use in the peripheral, coronary and
neuro vasculature for the intravascular introduction
of interventional/ diagnostic devices | Same as predicate |
| Device Description | The ENVOY Distal Access (DA) Guiding Catheter
is a variable stiffness, braided catheter with a large
non-tapered lumen that facilitates the intravascular
passage of interventional devices. The distal
segment is flexible for navigation into distal
vasculature. The catheter has an outer hydrophilic
coating that reduces friction during manipulation in
the vessel. The lubricious PTFE lined inner lumen
is designed to facilitate movement of the guide
wires and other devices. A luer fitting located on
the end of the catheter hub can be used to attach
accessories. The distal section of the catheter is
radiopaque to aid visualization under fluoroscopy,
and the distal tip is clearly distinguished by a
radiopaque marker. The catheter is available with
preshaped tips to facilitate positioning. A peel away
introducer is included to facilitate insertion into the
sheath. | The ENVOY Distal Access (DA) Guiding Catheter is a
variable stiffness, braided catheter with a large non-
tapered lumen that facilitates the intravascular passage
of interventional devices. The distal segment is flexible
for navigation into distal vasculature. The catheter has
an outer hydrophilic coating that reduces friction
during manipulation in the vessel. The lubricious PTFE
lined inner lumen is designed to facilitate movement of
the guide wires and other devices. A luer fitting located
on the end of the catheter hub can be used to attach
accessories. The distal section of the catheter is
radiopaque to aid visualization under fluoroscopy, and
the distal tip is clearly distinguished by a radiopaque
marker band which is approximately 3mm from the
distal tip. The catheter is available with preshaped tips
to facilitate positioning. A peel away introducer is
included to facilitate insertion into the sheath. |
| Product Code | DQY | Same as predicate |
| Classification | 21 CFR 870.1250, Class II | Same as predicate |
| Length/ Working
Length (cm) | 95cm & 105cm | Same as predicate |
| Catheter Inner
Diameter | 0.071" (1.8mm) | Same as predicate |
| Catheter Outer
Diameter | 6.0F (0.082"/2.0mm) | Same as predicate |
| Shapes | Straight
Multi-purpose D (MPD) | Straight
Multi-purpose D (MPD)
Multi-purpose C (MPC) |
| Transition Segment
Length | Standard Transition Segment Length
(Standard) | Standard Transition Segment Length
Standard
Shorter Transition Segment Lengths for Extra
Backup Support XB |
| Distal Tip
Radiopaque Marker | Pellethane Compound with Radiopaque Filler | Pellethane Compound with Radiopaque Filler & Metal
Marker Band |
| Reinforcing Member
(Braid) | Stainless Steel | Same as predicate |
| Liner | PTFE Liner | Same as predicate |
| Sterilization | EtO | Same as predicate |
| Product Shelf-Life | 1 year | 3 years |
Table 2B provides a packaging comparison between the existing ENVOY® Distal Access (DA) Guiding Catheter, the ENVOY Guiding Catheter and proposed ENVOY® Distal Access (DA) Guiding Catheter.
·
3
| Table 2B: Predicate Packaging Comparison Information | |||
|---|---|---|---|
| Description | Predicate Device Packaging: | ||
| ENVOY® DA Guiding Catheter | |||
| (K120229) | Predicate Device Packaging: | ||
| ENVOY® Guiding Catheter | |||
| (K093184) | This Submission: | ||
| Proposed Device Packaging | |||
| ENVOY® DA Guiding Catheter | |||
| Dimensions | |||
| Pouch Size | 49.21" x 3.95" | 46.5" x 4.0" | 49.91" x 4.09" |
| Carton Size | 47"x 4" x 0.75" | 47" x 4" x 0.75" | Same as K120229 |
| Mounting Card | 46"x 2.75" x 0.012" | 42.75" x 2.687" | Same as K120229 |
| Material | |||
| Pouch Material | Top Web: MRM4820PU (RLE- |
- 48GA PET/.002 LDPE
Bottom Web: Uncoated 1073B
Tyvek | Top Web: MRM002075 (M-2075)
48GA PET/.002 LDPE
Bottom Web: Uncoated 1073B Tyvek | Same as K093184 |
| Carton Material | .024" Clay Coated Solid Bleached
Surface | .024" Clay Coated Solid Bleached
Surface | Same as K120229 |
| Mounting Material | 0.012" Clay Coated Solid
Bleached Sulfate | Clay Coated Solid Bleached Sulfate | Same as K120229 |
| Sterilization | | | |
| Sterilization | EtO | Same | Same as predicate |
| Shelf-Life | | | |
| Packaging
Shelf-Life | 1 year | 3years | Same as K093184 |
H. Summary of Nonclinical Testing
The proposed ENVOY® Distal Access (DA) Guiding Catheter has the same intended use, sterilization process, function, mechanism of action, and clinical utility as the predicate ENVOY® Distal Access (DA) Guiding Catheter, and is similar in regard to design, material, and manufacturing. The testing conducted to assess the line extension and modifications include performance assessments per the following recognized standards:
| Table 3: Performance Standards | |
|---|---|
| Standard/Guidance/Directive | Description |
| BS EN ISO 11607-1: 2009 | Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for |
| Materials. Sterile Barrier Systems and Packaging Systems | |
| BS EN ISO 11135-1: 2007 | Sterilization of Healthcare products Ethylene Oxide: Part 1 Requirements for |
| development, validation and routine control of a sterilization process for medical devices | |
| BS EN ISO 10993-7: 2008 | Biological Evaluation of medical devices: Ethylene oxide sterilization residuals - Part 7 |
| BS EN ISO 10555-1: 2009 | Sterile. single use intravascular catheters Part 1: General requirements; Sterile |
| ISO 594-1: 1986 (E) | Conical fitting with a 6% (Luer) taper for syringes, needles and certain other medical |
| equipment: Part 1 - General Requirements | |
| ISO 594-2 : 1998 (E) | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical |
| equipment: Part 2 - Local fittings | |
| AAMI / ANSI HE75 : 2009 | Human Factors Engineering - Design of Medical Devices |
| BS EN 62366: 2008 | Medical Devices. Application of usability engineering to Medical Devices |
| BS EN ISO 10993-1: 2009 | Biological evaluation of medical devices: Evaluation & Testing - Part 1 |
| BS EN ISO 10993-5: 2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| BS EN ISO 10993-4: 2009 | Biological evaluation of medical devices Part 4: Selection for tests for interactions with |
| blood | |
| USP (2013) | Containers - Plastic. Physicochemical Tests |
| ISO 10993-10: 2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11: 2009 | Biological evaluation of medical devices Part11: Test for systemic toxicity |
| ISO 10993-3: 2009 | Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity, |
| and reproductive toxicity |
4
Bench Testing
Results of verification and validation testing that was conducted on the proposed ENVOY® Distal Access (DA) Guiding Catheter demonstrates that it performs as designed, is suitable for its intended use, is substantially equivalent to the predicate device and therefore, does not raise any new questions of safety and effectiveness. Appropriate testing was identified based on a review of the products' risk analyses and previous validation and verification testing.
The following Verification and Validation tests were conducted to verify the modified design ENVOY® Distal Access (DA) Guiding Catheter:
- . Visual Inspection
- . Catheter Shape
- Catheter Dimensional Verification ◆
- � Tensile Strength Testing
- Hydrophilic Coating Integrity ◆
- System Liquid Leakage Testing .
- Delamination of PTFE Liner Testing .
- Lateral Stiffness Testing .
- Linear Stiffness Testing
- Back-Up Support
- Track Testing .
- Sheath Introducer Compatibility .
- Hub Luer Taper ●
- System Air Leakage ●
- . Shaft Peel Strength
The following Packaging Validation Testing was conducted with the proposed ENVOY® Distal Access (DA) Guiding Catheter:
- Visual Inspection .
- Dve Leak
- Seal Strength .
The following Biocompatibility Testing was conducted with the proposed ENVOY® Distal Access (DA) Guiding Catheter:
- . In Vitro Cytotoxicity – MEM Elution
- · · Sensitization Guinea Pig Maximization
- Intracutaneous/Irritation Reactivity .
- Acute Systemic Toxicity .
5
Page 28 of 109 K140080
- Material Mediated Pyrogenicity .
- . Genotoxicity
- o · In Vitro Bacterial Mutagenicity Ames Assay
- o In Vitro Mouse Lymphoma Assay with extended treatment
- o In Vivo Mouse Micronucleus Assay
- Hemocompatibility .
- In Vitro Hemolysis Direct & Extract Method o
- Partial Thromboplastin Time (PTT) o
- Complement Activation C3a & SC5b-9 Assay 0
- In Vivo Thrombogenicity o
- . Physicochemical Aqueous Extraction Tests
In addition, the new sterile pouch packaging material was evaluated for in vitro cytotoxicity and was tested per ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.
The following Sterilization Test was conducted with the ENVOY® Distal Access (DA) Guiding Catheter:
. USP Limumus Amebocyte Lysate (LAL) Test - Kinetic Chromogenic Method
I. Animal Testing
No animal studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
J. Summary of Clinical testing:
No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Conclusion:
Based upon the design, materials, function, intended use, and the non-clinical testing performed by Codman it is concluded that the proposed ENVOY® Distal Access (DA) Guiding Catheter is substantially equivalent to the current ENVOY® Distal Access (DA) Guiding Catheter (K120229), and therefore, does not raise any new questions of safety and effectiveness.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that resemble a bird in flight. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
April 24, 2014
Codman & Shurtleff. Inc. Hannah Foley Regulatory Affairs Specialist II 325 Paramount Dr. Raynham, MA 02767-0350 US
Re: K140080
Trade/Device Name: ENVOY Distal Access (DA) Guiding Catheter, 6F, 95cm & 105cm. Straight & XB. MPD & XB. MPC & XB Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 26, 2014 Received: March 27, 2014
Dear Ms. Folev.
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. Iisting 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.
7
Page 2 - Ms. Foley
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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours, Bram D. Zuckerm
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
8
Indications for Use
K140080 510(k) Number (if Known):
Device Name: ENVOY® Distal Access (DA) Guiding Catheter
Indications for Use:
The ENVOY® Distal Access (DA) Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.
Prescription Use: _ X (Part 21 CFR 801Subpart D)
:
AND/OR
Over-The-Counter Use: (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)