510(k) K090555

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 by Maquet Cardiopulmonary, AG — Product Code DTR

K090555 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30". The FDA issued a decision of Substantially Equivalent on December 23, 2009. 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.