# K970854: 5 FR  and 6 FR Infiniti Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Sep 30, 1997 after 204 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921310 (1992). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960975: 1-4F Infiniti Angiographic Catheter, Cordis Corp. (1996) Summary page 1.
- K921310: Cordis 6 French Paragon Angiographic Catheter, Cordis Corp. (1992) Summary page 1.

## Most influential descendants
- K051561: Asahi Angiographic Catheter (2005), 2 descendants of its own
- K090427: Ursa Angiographic Catheter (2010), 1 descendant of its own
- K082559: Spectranetics Cross-Pilot Turbo Elite Support Catheter (2008), 1 descendant of its own
- K232573: INFINITI™ Ambi Angiographic Catheter (2023), 0 descendants of its own
- K123818: Ursa Angiographic Catheter (2013), 0 descendants of its own

## Recalls of this device
- Sep 26, 2023 · Class I · Z-0286-2024: Non-sterile product labeled as sterile was distributed.
- Nov 7, 2022 · Class II · Z-0720-2023: There is a potential for separation at the male connector.
- Jun 26, 2006 · Not classified · Z-1240-06: The tip of the catheter may separate from the body during operation.

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

Source page: https://510kreport.com/device/K970854
Methodology: https://510kreport.com/methodology