510(k) K051209 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
LEVITRONIX CENTRIMAG BACK-UP CONSOLE
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 8, 2005 |
| Received | May 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2008 | Levitronix, Llc Levitronix CentriMag Back-Up Console
Article Number: 201-30200; extracorporeal blood circulation system. Terminated |
KFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.