510(k) K973475 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
| Applicant | Medtronic Vascular, Anaheim CA, US |
| Decision | Substantially Equivalent, Nov 20, 1997 |
| Received | Sep 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973475
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.