510(k) K861403 ยท LDF Electrode, Pacemaker, Temporary
TB SERIES BIPOLAR PACING LEADS
| Applicant | Oscor Medical Corp., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Jun 27, 1986 |
| Received | Apr 15, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2018 | Oscor, Inc. TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed Terminated |
LDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.