# K960406: Braun Hemostasis Introducers

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 12, 1996 after 74 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 K895044 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895044: Dual Guide Introducer Catheter, Cook, Inc. (1990) Summary page 1.
- K945396: Fluoro-Tip (R) Hemostasis Valve Introducer Set, B.Braun Medical, Inc. (1995) Summary page 1.

## Indications for use
The Braun Hemostasis Valve Introducer Kits are designed to facilitate percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.

Source page: https://510kreport.com/device/K960406
Methodology: https://510kreport.com/methodology