510(k) K162054 ยท DTE Pulse-Generator, Pacemaker, External
Medtronic Temporary External Pacemaker 53401
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Jul 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162054
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Single Chamber Temporary External Pacemaker, Model 53401 Terminated |
DTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.