510(k) K964907 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT
| Applicant | Sorin Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 21, 1997 |
| Received | Dec 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964907
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.