510(k) K013915 ยท DTZ Oxygenator, Cardiopulmonary Bypass
D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER
| Applicant | Dideco S.P.A., Arvada CO, US |
| Decision | Substantially Equivalent, Dec 27, 2001 |
| Received | Nov 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013915
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.