510(k) K915547 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Sep 9, 1993 |
| Received | Dec 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915547
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.