510(k) K132166

VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT by Maquet Cardiopulmonary, AG — Product Code DTN

K132166 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT". The FDA issued a decision of Substantially Equivalent on October 30, 2013. 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.