# K760388: Catheter, Vein (Venofix)

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Instruments
- Decided: Nov 2, 1976 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 26, 2016 · Class II · Z-1703-2016: Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.

Source page: https://510kreport.com/device/K760388
Methodology: https://510kreport.com/methodology