510(k) K062429 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
| Applicant | Edwards Lifesciences Research Medical, Midvale UT, US |
| Decision | Substantially Equivalent, Sep 27, 2006 |
| Received | Aug 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062429
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.