510(k) K111658 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jun 28, 2011 |
| Received | Jun 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111658
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.