# K001346: Ultimum Hemostasis Introducer, Model 4076XX

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Inc.
- Decided: May 24, 2000 after 26 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
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
- K091137: Ultimum/Engage/Engage TR (2009), 2 descendants of its own
- K093130: Engage TR Introducer (2009), 0 descendants of its own
- K092575: Engage/Engage TR (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K001346
Methodology: https://510kreport.com/methodology