# K965106: Elc 35-UP Model Number 116015 and Elc 54-UP Model Number 115606

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jan 27, 1998 after 403 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 ELC xx-UP epicardial sutureless screw-in lead is indicated for unipolar pacing and sensing in the ventricle when an epicardial lead is preferred, or when a transvenous lead cannot provide satisfactory results or is contraindicated. Epicardial leads are well suited for situations where heart stimulation is necessary, for example, after open heart surgery, or based upon the patient’s age or heart condition (e.g., in young patients who have not reached full physical maturity and risk potential lead dislodgement). Epicardial leads are also indicated in situations where transvenous access is not available or is contraindicated.

Source page: https://510kreport.com/device/K965106
Methodology: https://510kreport.com/methodology