510(k) K150246 ยท DTE Pulse-Generator, Pacemaker, External
Medtronic Model 5392 External Pulse Generator (EPG)
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Feb 18, 2015 |
| Received | Feb 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Dual Chamber Temporary External Pacemaker, Model 5392.
Product Usage:
The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a cl Terminated |
DTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.