510(k) K001021 ยท DTZ Oxygenator, Cardiopulmonary Bypass
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Apr 25, 2000 |
| Received | Mar 30, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001021
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.