510(k) K162958 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 1, 2017 |
| Received | Oct 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162958
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.