510(k) K090051

LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 by Levitronix, LLC — Product Code KFM

K090051 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052". The FDA issued a decision of Substantially Equivalent on October 8, 2009. 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.