VISTA BRITE TIP CATHETERS

K962830 · Cordis Corp. · DQY · Oct 17, 1996 · Cardiovascular

Device Facts

• Record ID: K962830
• Device Name: VISTA BRITE TIP CATHETERS
• Applicant: Cordis Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 17, 1996
• 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

Single-lumen guiding catheter; nylon body reinforced with stainless steel braid wire; transition segments utilize varying durometer nylons for stiffness gradient; distal 'Brite Tip' segment composed of pellethane with radiopaque filler for atraumatic navigation. Used by physicians in clinical settings for coronary and peripheral vascular access; facilitates delivery of diagnostic/interventional 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; pellethane tip with radiopaque filler; variable durometer segments for stiffness transition. Non-powered, manual device.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into coronary and 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 (K962830)

Submission Summary (Full Text)

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# PREMARKET NOTIFICATION 510(k)
## Cordis Corporation

Cordis Guiding Catheter

OCT 17 1996

## SUMMARY OF SAFETY AND EFFECTIVENESS

### I. General Provisions:

K962830

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

### II. Name of Predicate Devices:

Cordis Vista Brite Tip

### 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 and 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 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, materials, indication for use and performance characteristics to other commercially available guiding catheters.