510(k) K041979

MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 by Quest Medical, Inc. — Product Code DTR

K041979 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260". The FDA issued a decision of Substantially Equivalent on September 2, 2004. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.