510(k) K892664 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CARDIOPULMONARY SUPPORT (CPS) SYSTEM
| Applicant | Bard Cardiosurgery Div, Billerica MA, US |
| Decision | Substantially Equivalent, Feb 13, 1990 |
| Received | Apr 13, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892664
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.