510(k) K022450 ยท DTZ Oxygenator, Cardiopulmonary Bypass
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Oct 22, 2002 |
| Received | Jul 26, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K022450
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.