# K910608: Permanent Implantable FH Endocardial Leads W/Tip

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, GmbH & Co.
- Decided: Jul 30, 1991 after 168 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.
3 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K994240: EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133 (2000), 1 descendant of its own
- K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP (2003), 0 descendants of its own
- K993139: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K910608
Methodology: https://510kreport.com/methodology