1-4F INFINITI ANGIOGRAPHIC CATHETER

K960975 · Cordis Corp. · DQO · Apr 2, 1996 · Cardiovascular

Device Facts

• Record ID: K960975
• Device Name: 1-4F INFINITI ANGIOGRAPHIC CATHETER
• Applicant: Cordis Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Apr 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Cordis 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Device Story

Diagnostic intravascular catheter; 4F diameter; braided proximal shaft; radiopaque tip. Used by physicians in clinical settings for angiographic procedures. Device facilitates delivery of radiopaque contrast medium to specific vascular sites; enables visualization of vasculature via imaging. Benefits include precise contrast delivery for diagnostic assessment.

Clinical Evidence

Bench testing only; biocompatibility testing performed on materials.

Technological Characteristics

4F diameter; braided proximal shaft; radiopaque tip. Materials biocompatibility verified. Non-powered, passive diagnostic catheter.

Indications for Use

Indicated for patients requiring delivery of radiopaque contrast medium to selected sites in the vascular system during angiographic procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Cordis Corporation 4F Nylex Angiographic Catheter (K930479)
• Cordis Corporation Paragon Angiographic Catheter (K921310/A)

Submission Summary (Full Text)

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K960975

# PREMARKET NOTIFICATION 510(k)
Cordis Corporation
4F Infiniti Angiographic Catheter

## SUMMARY OF SAFETY AND EFFECTIVENESS

### I. General Provisions

- Common or Usual Name: Diagnostic Intravascular Catheter and Percutaneous Catheter
- Proprietary Name: Cordis 4F Infiniti™ Angiographic Catheter

### II. Name of Predicate Devices

- Cordis Corporation 4F Nylex Angiographic Catheter (K930479)
- Cordis Corporation Paragon Angiographic Catheter (K921310/A)

### 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. Intended Use and Device Description

The Cordis 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vascular system. The catheter is 4F in diameter with a braided proximal shaft and radiopaque tip.

### VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Corporation Infiniti Angiographic Catheters.

### VII. Summary of Substantial Equivalence

The Cordis 4F Infiniti Angiographic Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available angiographic catheters.

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