510(k) K131179

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR by Thoratec Corp — Product Code DWA

K131179 is an FDA 510(k) premarket notification submitted by Thoratec Corp for the device "CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR". The FDA issued a decision of Substantially Equivalent on July 18, 2013. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380.