# K003729: Ultimum EV Hemostasis Introducer (14F), Ultimum EV Hemostasis Introducer (16F), Ultimum EV Hemostasis Introducer (18F),

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jan 3, 2001 after 30 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K023447: Modification to Ultimum EV Hemostasis Introducer (22F) (2002), 1 descendant of its own
- K140327: Ultimum EV Hemostasis Introducer (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K003729
Methodology: https://510kreport.com/methodology