510(k) K101153

QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD by Maquet Cardiopulmonary, AG — Product Code DTZ

K101153 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD". The FDA issued a decision of Substantially Equivalent on December 8, 2010. 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.