# K971086: Radial and Femoral Artery Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Dec 19, 1997 after 269 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K810675 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810675: Arrow Radial Artery Catheterization Set, Arrow Intl., Inc. (1981) Summary page 1.

## Indications for use
The Radial and Femoral Artery Catheter is a device that is utilized to access an artery for blood sampling and blood pressure monitoring.

Source page: https://510kreport.com/device/K971086
Methodology: https://510kreport.com/methodology