510(k) K061369 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Aug 22, 2006 |
| Received | May 17, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061369
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.