510(k) K072583

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 by Maquet Cardiopulmonary, AG — Product Code DTR

K072583 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30". The FDA issued a decision of Substantially Equivalent on April 4, 2008. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Maquet Cardiopulmonary, AG has at least 10 other 510(k) clearances on record.