510(k) K083340 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Nov 26, 2008 |
| Received | Nov 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083340
| 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.