510(k) K071572

CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER by Terumo Corp. — Product Code DTZ

K071572 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on July 23, 2007. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Terumo Corp. has at least 10 other 510(k) clearances on record.