510(k) K133265

QUADROX-IR ADULT AND SMALL ADULT by Maquet Cardiopulmonary, AG — Product Code KFM

K133265 is an FDA 510(k) premarket notification submitted by Maquet Cardiopulmonary, AG for the device "QUADROX-IR ADULT AND SMALL ADULT". The FDA issued a decision of Substantially Equivalent on November 12, 2013. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Maquet Cardiopulmonary, AG has at least 10 other 510(k) clearances on record.