510(k) K031946 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
| Applicant | Edwards Lifesciences, LLC, Milpitas CA, US |
| Decision | Substantially Equivalent, Nov 3, 2003 |
| Received | Jun 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031946
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.