510(k) K132829

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS by Maquet Cardiopulmonary, AG — Product Code DTZ

K132829 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS". The FDA issued a decision of Substantially Equivalent on October 8, 2013. 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.