510(k) K102464

QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING by Maquet Cardiopulmonary, AG — Product Code DTZ

K102464 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING". The FDA issued a decision of Substantially Equivalent on March 4, 2011. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Maquet Cardiopulmonary, AG has at least 10 other 510(k) clearances on record.