# K831695: Temp. Cardiac Pacing Wire Tme 60/61/65

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Oct 20, 1983 after 148 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- 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
- Jul 25, 2012 · Class II · Z-0165-2013: Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag t

Source page: https://510kreport.com/device/K831695
Methodology: https://510kreport.com/methodology