# K033527: Intradyn Pediatric Hemostasis Introducer

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Feb 5, 2004 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: 2 generations back to K871153 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K955820: Braun Hemostasis Introducers, B.Braun Medical, Inc. (1996) Summary page 1.
- K910861: Percutaneous Introd W/Sideport/Three-Way Stopcock, Daig Corp. (1991) Summary page 1.

## Indications for use
The Intradyn Pediatric Hemostasis Introducers are designed to facilitate percutaneous introduction of catheters into the vascular system of pediatric patients while minimizing blood loss.

Source page: https://510kreport.com/device/K033527
Methodology: https://510kreport.com/methodology