510(k) K232132 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
LifeSPARC System
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Aug 3, 2023 |
| Received | Jul 18, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232132
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.