# K972574: Stela Model UJ45 Pacing Leads

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: Jan 8, 1998 after 182 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- 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 K896742 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K896742: Focus J81F, J83F, J41F, J43F Pacing Leads, Ela Medical, Inc. (1990) Summary page 1.
- K963698: CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4, International Biophysics Corp. (1997) Summary page 1.

## Most influential descendants
- K993448: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads (2000), 0 descendants of its own

## Indications for use
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. J-shaped leads are intended for permanent pacing and sensing of the atrium.

Source page: https://510kreport.com/device/K972574
Methodology: https://510kreport.com/methodology