Who is the manufacturer of 4F NYLEX ANGIOGRAPHIC CATHETER?

Cordis Corp. submitted the Traditional clearance for 4F NYLEX ANGIOGRAPHIC CATHETER (K962759).

What is the FDA product code for 4F NYLEX ANGIOGRAPHIC CATHETER?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for 4F NYLEX ANGIOGRAPHIC CATHETER?

510(k) clearance (submission type: Traditional).

4F NYLEX ANGIOGRAPHIC CATHETER

Q: What are the predicate devices for 4F NYLEX ANGIOGRAPHIC CATHETER?

Cordis Corporation 4F Nylex Angiographic Catheter; Cordis Corporation 4F Infiniti Angiographic Catheter.

K962759 · Cordis Corp. · DQO · Oct 10, 1996 · Cardiovascular

Device Facts

Record ID	K962759
Device Name	4F NYLEX ANGIOGRAPHIC CATHETER
Applicant	Cordis Corp.
Product Code	DQO · Cardiovascular
Decision Date	Oct 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for patients requiring delivery of radiopaque contrast medium to selected sites in the vasculature.

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
Cordis Corporation 4F Infiniti Angiographic Catheter

Related Devices

K960975 — 1-4F INFINITI ANGIOGRAPHIC CATHETER · Cordis Corp. · Apr 2, 1996
K991673 — CORDIS TEMPO ANGIOGRAPHY CATHETER · Cordis Corp. · May 26, 1999
K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) · Cook, Inc. · Dec 14, 2012
K970854 — 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER · Cordis Corp. · Sep 30, 1997
K971646 — 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER · Cordis Corp. · Jul 14, 1997

Submission Summary (Full Text)

{0} 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.