510(k) K912604 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
| Applicant | Aries Medical, Inc., Chelmsford MA, US |
| Decision | Substantially Equivalent, Oct 28, 1991 |
| Received | May 31, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912604
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.