# K945396: Fluoro-Tip (R) Hemostasis Valve Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 13, 1995 after 130 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K955820: Braun Hemostasis Introducers (1996), 1 descendant of its own
- K033527: Intradyn Pediatric Hemostasis Introducer (2004), 0 descendants of its own
- K960406: Braun Hemostasis Introducers (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K945396
Methodology: https://510kreport.com/methodology