510(k) K033987 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
| Applicant | Dideco S.P.A., Waltham MA, US |
| Decision | Substantially Equivalent, Jan 8, 2004 |
| Received | Dec 23, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033987
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.