510(k) K033714 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Dec 11, 2003 |
| Received | Nov 26, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033714
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.