# K955820: Braun Hemostasis Introducers

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 25, 1996 after 90 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
Longest line of descent: 1 generation back to K871153 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894446: Angeion Hemostasis Valve Introducer, Angeion Corp. (1989) Summary page 1.
- K931743: Burron Cardiovascular Angestat (TM), B.Braun Medical, Inc. (1993) Summary page 1.
- K871153: Catheter Introducer, Angeion Corp. (1987) Summary page 1.
- K930057: Angestat Fluoro-Tip Hemostasis Introducer Set, B.Braun Medical, Inc. (1993) Summary page 1.
- K945396: Fluoro-Tip (R) Hemostasis Valve Introducer Set, B.Braun Medical, Inc. (1995) Summary page 1.

## Most influential descendants
- K033527: Intradyn Pediatric Hemostasis Introducer (2004), 0 descendants of its own

## Indications for use
For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

Source page: https://510kreport.com/device/K955820
Methodology: https://510kreport.com/methodology