# K961745: Braun Percutaneous Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Sep 17, 1996 after 134 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770561 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810460: Burron Percutaneous Inducer Set, Burron Medical Products, Inc. (1981) Summary page 1.
- K894446: Angeion Hemostasis Valve Introducer, Angeion Corp. (1989) Summary page 1.
- K894343: Daig Percutaneous Catheter Intro. & Removable Hemo, Daig Corp. (1989) Summary page 1.
- K884494: Daig Obturator, Catheter Introducer, Daig Corp. (1989)
- K771982: 888 Arterial/Venous Catheter Introducer, Usci, Div. C.R. Bard, Inc. (1977) Summary page 1.
- K770561: Catheter,Percutaneous Introduc. & Sheath, Usci, Div. C.R. Bard, Inc. (1977) Summary page 1.
- K780126: Dilator, Vessel & Introducer, Sheath, Argon Medical Corp. (1978) Summary page 1.
- K850820: Percutaneous Catheter Introducer W/Cath-Seal & Sid, Universal Medical Instrument Corp. (1985) Summary page 1.
- K932733: Cordis Catheter Sheath Introducer, Cordis Corp. (1993) Summary page 1.

## Recalls of this device
- Apr 16, 2004 · Not classified · Z-1133-04: Catheter separated from the hub.

## Indications for use
The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

Source page: https://510kreport.com/device/K961745
Methodology: https://510kreport.com/methodology