# K181836: 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters

- Pathway: 510(k) (Special)
- Applicant: Cordis, A Cardinal Health Company
- Decided: Aug 8, 2018 after 29 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: 2 generations back to K921310 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960975: 1-4F Infiniti Angiographic Catheter, Cordis Corp. (1996) Summary page 4.
- K971646: 4F Nylex Angiography Catheter/5F Nylex Angiography Catheter, Cordis Corp. (1997) Summary page 5.
- K991673: Cordis Tempo Angiography Catheter, Cordis Corp. (1999) Summary page 5.

## 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. Cordis Nylex™ Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system. Cordis Tempo™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

Source page: https://510kreport.com/device/K181836
Methodology: https://510kreport.com/methodology