510(k) K160260 ยท LDF Electrode, Pacemaker, Temporary
Tempo Temporary Pacing Lead
| Applicant | Biotrace Medical, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Oct 25, 2016 |
| Received | Feb 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160260
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.