510(k) K173716

MPS2 Myocardial Protection System Console by Quest Medical, Inc. — Product Code DTR

K173716 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "MPS2 Myocardial Protection System Console". The FDA issued a decision of Substantially Equivalent on October 1, 2018. 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.