# K902002: Models 5069/5071 Myocardial Pacing Leads

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Sep 26, 1990 after 147 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Feb 25, 2010 · Not classified · Z-1200-2010: Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury d

Source page: https://510kreport.com/device/K902002
Methodology: https://510kreport.com/methodology