ENVOY GUIDING CATHETERS

K093184 · Codman & Shurtleff, Inc. · DQY · Nov 6, 2009 · Cardiovascular

Device Facts

• Record ID: K093184
• Device Name: ENVOY GUIDING CATHETERS
• Applicant: Codman & Shurtleff, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 6, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Device Story

The ENVOY Guiding Catheter is a percutaneous catheter used by clinicians to facilitate the delivery of interventional or diagnostic devices into the peripheral, coronary, and neurovasculature. It acts as a conduit for these devices, allowing for precise placement within the vascular system. The device is used in clinical settings, such as catheterization labs, by physicians. It does not perform automated analysis or processing; it is a mechanical tool for vascular access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous catheter; biocompatible materials; intended for intravascular use; mechanical device without electronic components or software.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices in peripheral, coronary, or neurovasculature.

Regulatory Classification

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.

Predicate Devices

• ENVOY Guiding Catheter (K693184)

Submission Summary (Full Text)

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## SECTION 3. 510(k) SUMMARY

#### General Provisions l.

| Common Name: | Catheter, Percutaneous |
|-------------------|-------------------------|
| Proprietary Name: | ENVOY® Guiding Catheter |

#### ll. Name of Predicate Device:

Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter

NOV - 6 2009

### III. Classification Class II

Class II

#### IV. Performance Standards:

Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

#### V. Intended Use and Device Description:

The ENVOY Guiding Catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

#### VI. Biocompatibility:

All materials used in the ENVOY Guiding Catheters are biocompatible.

#### VII. Summary of Substantial Equivalence:

The ENVOY Guiding Catheters are substantially equivalent to the previously cleared ENVOY Guiding Catheters.

3

K693184

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Image /page/1/Picture/0 description: The image is a circular seal or logo. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized graphic that resembles a bird in flight or a flowing ribbon-like design. The overall impression is that of an official emblem, likely representing a government agency related to health and human services in the United States.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Codman & Shurtleff Inc. c/o Ms. Kate LaRose Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767

NOV - 6 2009

Re: K093184

Trade/Device Name: ENVOY® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: October 6, 2009 Received: October 9, 2009

Dear Ms. LaRose:

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.

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.

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Page 2 - Ms. Kate LaRose

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-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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm.for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

sumai R. Vachner

\$\omega\$

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K093184

Device Name: ENVOY® Guiding Catheters

Indications For Use: The ENVOY Guiding Catheter is intended for use un the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Richards

Division Sign-Off) (Division Sign-Old)
Division of Cardiovascular Devices

510(k) Number_Kod3784

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