510(k) K945065 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
| Applicant | Sorin Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 19, 1995 |
| Received | Oct 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945065
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.