510(k) K081221

LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE by Levitronix, LLC — Product Code DWA

K081221 is an FDA 510(k) premarket notification submitted by Levitronix, LLC for the device "LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE". The FDA issued a decision of Substantially Equivalent on June 19, 2008. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Levitronix, LLC has at least 10 other 510(k) clearances on record.