# K232573: INFINITI™ Ambi Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis US Corp
- Decided: Nov 21, 2023 after 88 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: 3 generations back to K921310 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970854: 5 FR  and 6 FR Infiniti Angiographic Catheter, Cordis Corp. (1997) Summary page 6.

## Indications for use
Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K232573
Methodology: https://510kreport.com/methodology