510(k) K100645 ยท DTZ Oxygenator, Cardiopulmonary Bypass
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 14, 2012 |
| Received | Mar 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100645
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.