510(k) K102919

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE by Maquet Cardiopulmonary, AG — Product Code DTN

K102919 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE". The FDA issued a decision of Substantially Equivalent on March 11, 2011. 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.