# K894446: Angeion Hemostasis Valve Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Angeion Corp.
- Decided: Nov 30, 1989 after 136 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
No predicates in its family tree.
3 later devices descend from it; 3 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
- K961745: Braun Percutaneous Introducer Set (1996), 0 descendants of its own

## Recalls of this device
- May 27, 2005 · Not classified · Z-1062-05: Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.

Source page: https://510kreport.com/device/K894446
Methodology: https://510kreport.com/methodology