# K023447: Modification to Ultimum EV Hemostasis Introducer (22F)

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Oct 31, 2002 after 16 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 K003729 (2001). 1 ancestor in all.
1 later device descends 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)
- K003729: Ultimum EV Hemostasis Introducer (14F), Ultimum EV Hemostasis Introducer (16F), Ultimum EV Hemostasis Introducer (18F),, St Jude Medical (2001) Summary page 1.

## Most influential descendants
- K140327: Ultimum EV Hemostasis Introducer (2014), 0 descendants of its own

## Indications for use
The UltimumTMEV 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/K023447
Methodology: https://510kreport.com/methodology