510(k) K090051 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 8, 2009 |
| Received | Jan 7, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2018 | Thoratec Switzerland GMBH Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.