510(k) K925369 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
| Applicant | Sorin Biomedica, Fiat, USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 26, 1993 |
| Received | Oct 23, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925369
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.