# K960975: 1-4F Infiniti Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Apr 2, 1996 after 22 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921310 (1992). 2 ancestors in all.
41 later devices descend from it; 5 cite it directly.
1 of 44 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930479: Nylex Catheters, Cordis Corp. (1993) Summary page 1.
- K921310: Cordis 6 French Paragon Angiographic Catheter, Cordis Corp. (1992) Summary page 1.

## Most influential descendants
- K992051: Radifocus Optitorque (1999), 32 descendants of its own
- K082561: Spectranetics Quick-Cross Extreme Support Catheters (2008), 18 descendants of its own
- K092396: Spectranetics Quick Cross Extreme Support Catheters (2009), 13 descendants of its own
- K082736: Radifocus Optitorque Angiographic Catheter (2008), 9 descendants of its own
- K970854: 5 FR  and 6 FR Infiniti Angiographic Catheter (1997), 7 descendants of its own

## Recalls of this device
- Jun 26, 2006 · Not classified · Z-1240-06: The tip of the catheter may separate from the body during operation.

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

Source page: https://510kreport.com/device/K960975
Methodology: https://510kreport.com/methodology