510(k) K100646 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Dec 16, 2010 |
| Received | Mar 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100646
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.