# K994334: Ultra-Flex Hemostasis Introducer. Model 406XXX

- Pathway: 510(k) (Special)
- Applicant: Daig Corp.
- Decided: May 15, 2000 after 144 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 K910861 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910861: Percutaneous Introd W/Sideport/Three-Way Stopcock, Daig Corp. (1991) Summary page 1.

## Indications for use
The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

Source page: https://510kreport.com/device/K994334
Methodology: https://510kreport.com/methodology