510(k) K190716 ยท LDF Electrode, Pacemaker, Temporary
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
| Applicant | Medtronic, Santa Ana CA, US |
| Decision | Substantially Equivalent, Aug 8, 2019 |
| Received | Mar 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190716
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.