# K971646: 4F Nylex Angiography Catheter/5F Nylex Angiography Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jul 14, 1997 after 70 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930479 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962759: 4F Nylex Angiographic Catheter, Cordis Corp. (1996) Summary page 1.
- K930479: Nylex Catheters, Cordis Corp. (1993) Summary page 1.
- K962362: Cordis Envoy & Vista Brite Tip Guiding Catheters, Cordis Corp. (1996) Summary page 1.

## Most influential descendants
- K181836: 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters (2018), 0 descendants of its own

## Indications for use
Cordis Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Source page: https://510kreport.com/device/K971646
Methodology: https://510kreport.com/methodology