# K993448: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: Apr 10, 2000 after 181 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: 2 generations back to K896742 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904255: Focus T41,T41F,T43, T43F,T44F, Elamedical (1991) Summary page 1.
- K963698: CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4, International Biophysics Corp. (1997) Summary page 1.
- K972574: Stela Model UJ45 Pacing Leads, Ela Medical, Inc. (1998) Summary page 1.

## Indications for use
ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers. ELA Medical Stela™ Model BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle. ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.

Source page: https://510kreport.com/device/K993448
Methodology: https://510kreport.com/methodology