# K953044: Unipolar & Bioplar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation & Passive Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Sep 27, 1996 after 455 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The BIOTRONIK TIR and TIJ pacing leads are safe and effective transvenous, implantable, endocardial leads used with implantable cardiac pacemakers.

Source page: https://510kreport.com/device/K953044
Methodology: https://510kreport.com/methodology