510(k) K973011 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
BPX80 BIO-PUMP (BPX80)
| Applicant | Medtronic Bio-Medicus, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Feb 25, 1998 |
| Received | Aug 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973011
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.