510(k) K090534

VENOUS HARDSHELL CARDIOTOMY RESERVIORS by Maquet Cardiopulmonary, AG — Product Code DTN

K090534 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "VENOUS HARDSHELL CARDIOTOMY RESERVIORS". The FDA issued a decision of Substantially Equivalent on December 23, 2009. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Maquet Cardiopulmonary, AG has at least 10 other 510(k) clearances on record.