VISTA BRITE TIP CATHETERS

K965211 · Cordis Corp. · DQY · Mar 11, 1997 · Cardiovascular

Device Facts

• Record ID: K965211
• Device Name: VISTA BRITE TIP CATHETERS
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 11, 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 or peripheral vascular systems.

Device Story

Single-lumen guiding catheter; nylon body reinforced with stainless steel braid wire; transition segments with varying durometer nylons 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 into coronary or peripheral vasculature. Benefits include improved trackability and atraumatic navigation through vascular anatomy.

Clinical Evidence

Bench testing only; biocompatibility testing successfully completed.

Technological Characteristics

Single-lumen catheter; nylon body; stainless steel braid wire reinforcement; Pellethane tip with radiopaque filler; variable durometer nylon transition segments.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into coronary or peripheral vascular systems.

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

K965211

MAR 11 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

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 or peripheral vascular systems.

Description: The Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless steel 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 durometer (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.