510(k) K141432

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH by Maquet Cardiopulmonary, AG — Product Code DTN

K141432 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH". The FDA issued a decision of Substantially Equivalent on July 7, 2014. 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.