510(k) K020271

LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 by Levitronix, LLC — Product Code KFM

K020271 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100". The FDA issued a decision of Substantially Equivalent on March 25, 2003. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Levitronix, LLC has at least 10 other 510(k) clearances on record.