510(k) K020271 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
| Applicant | Levitronix, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Mar 25, 2003 |
| Received | Jan 28, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K020271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2019 | Thoratec Switzerland GMBH CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System. Terminated |
KFM | None listed |
| 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 |
| Jul 23, 2008 | Levitronix, Llc Levitronix CentriMag Primary System,
Article Number: 201-30100; 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.