VISTA BRITE TIP CATHETERS

K963962 · Cordis Corp. · DQY · May 7, 1997 · Cardiovascular

Device Facts

• Record ID: K963962
• Device Name: VISTA BRITE TIP CATHETERS
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: May 7, 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, peripheral and neurovasculature.

Device Story

Single-lumen guiding catheter; nylon body reinforced with stainless steel braid wire; variable durometer nylon transition segments for stiffness gradient; soft pellethane tip with radiopaque filler. Used by physicians in clinical settings for intravascular access; facilitates delivery of interventional or diagnostic devices. Device provides trackability and support during procedures.

Clinical Evidence

Bench testing only; biocompatibility testing successfully completed.

Technological Characteristics

Single-lumen catheter; nylon body; stainless steel braid wire reinforcement; variable durometer nylon transition segments; pellethane tip with radiopaque filler. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into coronary, peripheral, 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

• Cordis Vista Brite Tip
• Cordis Endovascular Systems, ENVOY Guiding Catheters

Submission Summary (Full Text)

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PREMARKET NOTIFICATION 510(k)
Cordis Corporation
Cordis Guiding Catheter
K963962

# SUMMARY OF SAFETY AND EFFECTIVENESS

MAY - 7 1997

## 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

## III. Classification

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. Indication For Use and Device Description

Indications: **Vista Brite Tip**: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral and neurovasculature.

Description: The Vista Brite Tip Guiding Catheters are single lumen catheters which 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.