510(k) K191557 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
CentriMag Acute Circulatory Support System
| Applicant | Thoratec Corporation (Now Part of Abbott), Pleasanton CA, US |
| Decision | Substantially Equivalent, Jul 10, 2019 |
| Received | Jun 12, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191557
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.