← Product Code [DQO](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO) · K962759

# 4F NYLEX ANGIOGRAPHIC CATHETER (K962759)

_Cordis Corp. · DQO · Oct 10, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K962759

## Device Facts

- **Applicant:** Cordis Corp.
- **Product Code:** [DQO](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO.md)
- **Decision Date:** Oct 10, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1200
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

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

## Device Story

4F diameter single lumen catheter with radiopaque tip; used for delivery of radiopaque contrast medium to selected vascular sites. Operated by physicians in clinical settings during angiographic procedures. Device facilitates visualization of vasculature via contrast media delivery.

## Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993-1.

## Technological Characteristics

4F diameter single lumen catheter; radiopaque tip. Materials tested for biocompatibility per ISO 10993-1.

## Regulatory 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
- Cordis Corporation 4F Infiniti Angiographic Catheter

## Submission Summary (Full Text)

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>
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PREMARKET NOTIFICATION 510(k)
Cordis Corporation
4F Nylex Angiographic Catheter Modification
0-000015
K962759
OCT 10 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. General Provisions

Common or Usual Name: Diagnostic Intravascular Catheter and Percutaneous Catheter

Proprietary Name: Cordis 4F Nylex™ Angiographic Catheter

## II. Name of Predicate Devices

Cordis Corporation 4F Nylex Angiographic Catheter

Cordis Corporation 4F Infiniti Angiographic Catheter

## 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 Nylex Angiographic Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature. The catheter is a 4F diameter single lumen catheter with a radiopaque tip.

## VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the materials used for the Cordis Corporation 4F Nylex Angiographic Catheters per ISO 10993-1.

## VII. Summary of Substantial Equivalence

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

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K962759](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K962759)

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