510(k) K961869 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
| Applicant | Sorin Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 12, 1996 |
| Received | May 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961869
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.