510(k) K004001 ยท DTZ Oxygenator, Cardiopulmonary Bypass
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
| Applicant | Dideco, Arvada CO, US |
| Decision | Substantially Equivalent, Oct 4, 2001 |
| Received | Dec 26, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K004001
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.