6F ENVOY GUIDING CATHETER

K982770 · Cordis Corp. · DQY · Aug 18, 1998 · Cardiovascular

Device Facts

• Record ID: K982770
• Device Name: 6F ENVOY GUIDING CATHETER
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.

Device Story

The VISTA BRITE TIP and ENVOY Guiding Catheters are single-lumen catheters used by clinicians to facilitate the delivery of interventional or diagnostic devices into the coronary, peripheral, and neuro vasculature. The device features a nylon body reinforced with a tightly wound stainless steel braid wire. A transition segment utilizes nylons of varying durometers to provide a gradual decrease in stiffness from the catheter body to the tip. The device is used in clinical settings to assist in navigating the vasculature for therapeutic or diagnostic procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

6 French single-lumen catheter; nylon body; stainless steel braid wire reinforcement; variable durometer nylon transition segment for stiffness gradient; biocompatible materials.

Indications for Use

Indicated for intravascular introduction of interventional or diagnostic devices into the coronary, peripheral, and neuro vasculature.

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

• Cordis Corporation VISTA BRITE TIP Guiding Catheter
• Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter

Submission Summary (Full Text)

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Attachment 4

AUG 1 8 1998

K982770

## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: VISTA BRITE TIP and ENVOY Guiding Catheter<br>Common/Classification Name: Percutaneous Catheter |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | • Cordis Corporation VISTA BRITE TIP Guiding Catheter<br>• Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter |
| Classification | Class II |
| Performance<br>Standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established<br>performance standards. |
| Intended Use<br>and Device<br>Description | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for<br>intravascular introduction of interventional/diagnostic devices into the coronary,<br>peripheral, and neuro vasculature. |
| | The device description of the VISTA BRITE TIP and ENVOY Guiding Catheters is<br>as follows.<br>• 6 French |
| | • Single lumen catheter featuring a nylon body reinforced with a tightly wound<br>stainless steel braid wire<br>• The transition segment is designed with nylons of different durometers (stiffness)<br>to provide a gradual decrease in material stiffness from the catheter body to the<br>tip. |
| Biocompatibility | All materials used in the VISTA BRITE TIP and ENVOY Guiding Catheters are<br>biocompatible. |
| Summary of<br>Substantial<br>Equivalence | The VISTA BRITE TIP and ENVOY Guiding Catheters are substantially equivalent<br>to the previously cleared VISTA BRITE TIP and ENVOY Guiding Catheters. |

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1998

Mr. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Corporation Cordis Endovascular 14000 N.W. 57th Court Miami Lakes, FL 33014

Re: K982770 Trade Name: 6F Envoy Guiding Catheter Requlatory Class: II Product Code: DQY Dated: July 22, 1998 Received: July 23, 1998

Dear Mr. Schneider:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. · In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this

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Page 2 - Mr. Martine D. Schneider

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callaha Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## . Attachment 2

## Indications for Use Statement

| 510(k) Number<br>(if known) | The 510(k) number has not yet been assigned. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | VISTA BRITE TIP and ENVOY Guiding Catheters |
| Indications for<br>Use | The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for<br>intravascular introduction of interventional/diagnostic devices into the coronary,<br>peripheral, and neuro vasculature. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tia A Re

(Division Sign-Off) Division of · a ascult: and Neurologics Devices

510(k) Number K982770

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_