# K874531: Polyflex (R) Epicardial 439-04 Implant Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics, Inc.
- Decided: Jan 7, 1988 after 65 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K960281: Implantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K874531
Methodology: https://510kreport.com/methodology