510(k) K934847 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
| Applicant | Sorin Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 15, 1994 |
| Received | Oct 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Cobe Cardiovascular, Inc Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt Terminated |
DTN | None listed |
| Jul 2, 2003 | Cobe Cardiovascular, Inc Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. Terminated |
DTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.