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.
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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.
