VISTA BRITE TIP GUIDING CATHETERS

K972978 · Cordis Corp. · DQY · Oct 21, 1997 · Cardiovascular

Device Facts

• Record ID: K972978
• Device Name: VISTA BRITE TIP GUIDING CATHETERS
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems.

Device Story

Cordis Vista Brite Tip is a single-lumen guiding catheter used by clinicians to facilitate the introduction of interventional or diagnostic devices into coronary or peripheral vasculature. The device features a nylon body reinforced with a stainless steel braid wire for structural integrity. It utilizes a multi-durometer design to provide a gradual decrease in stiffness from the catheter body to the tip. The distal 'Brite Tip' segment is constructed from pellethane with a radiopaque filler to provide a soft, visible tip for navigation. The device is intended for use in clinical settings by trained medical professionals.

Clinical Evidence

Bench testing only. Biocompatibility testing was successfully completed.

Technological Characteristics

Single-lumen catheter; nylon body with stainless steel braid wire reinforcement; multi-durometer transition segments; pellethane tip with radiopaque filler. Sterilization method not specified.

Indications for Use

Indicated for intravascular introduction of interventional or diagnostic devices into the coronary and peripheral vascular systems. Prescription use only.

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 Vista Brite Tip (K972978)
• Cordis Endovascular Systems, ENVOY Guiding Catheters

Submission Summary (Full Text)

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## PREMARKET NOTIFICATION 510(k) Cordis Corporation

K972978

## Cordis Guiding Catheter

### SUMMARY OF SAFETY AND EFFECTIVENESS OCT 2 ! 1097

#### I. General Provisions:

Common or Usual Name: Percutaneous Catheter Proprietary Name: Cordis Vista Brite Tip®

#### II. Name of Predicate Devices:

Cordis Vista Brite Tip Cordis Endovascular Systems, ENVOY Guiding Catheters

#### Classification Class II III.

- Performance standards have not been established by the FDA IV. Performance Standards: under section 514 of the Food, Drug and Cosmetic Act.
#### Indication For Use and Device Description V.

- Vista Brite Tip: The guiding catheter is intended for use for intravascular Indications: introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.
- The Vista Brite Tip Guiding Catheters are single lumen catheters which Description: features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.

#### VI. Biocompatibility:

All appropriate biocompatibility tests for the guiding catheters were successfully completed.

#### VII. Summary of Substantial Equivalence:

The Cordis Guiding Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available guiding catheters.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

OCT 21 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katherine Trevisol Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014

Re: K972978 7F 0.078" I.D. Vista Brite Tip Guiding Catheters Regulatory Class: II (two) Product Code: 74 DQY Dated: October 9, 1997 Received: October 10, 1997

Dear Ms. Trevisol:

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 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 aduiteration.

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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 regulations.

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Page 2 - Ms. Katherine Trevisol

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 leqally 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 requlation (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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): To be assigned by FDA

Device Name: Cordis 7F 0.078" I.D. Vista Brite Tip Guiding Catheters

Indications for Use:

The guiding catheter is intended for use for intravascular introduction of
the suiding cather is a local and to the seconary and peripheral vascula The guiding catheter is intended for use for intravasoular involument wascular systems.
interventional/diagnostic devices into the coronary and peripheral vascular systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tre A. Pa

(Division Sign-೧೯) Division of Curce. Assentar, Respiratory, and Manrelate

510(k) Number ic977978

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_