510(k) K090004 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 15, 2009 |
| Received | Jan 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090004
| 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.