510(k) K831695 ยท LDF Electrode, Pacemaker, Temporary
TEMP. CARDIAC PACING WIRE TME 60/61/65
| Applicant | Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Oct 20, 1983 |
| Received | May 25, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2012 | Oscor, Inc. Myocardial Heart Wires
Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. Terminated |
LDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.