510(k) K101186 ยท DTP Defoamer, Cardiopulmonary Bypass
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
| Applicant | Medtronic Perfusion Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 3, 2010 |
| Received | Apr 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101186
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.