510(k) K071494

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER by Terumo Corp. — Product Code DTZ

K071494 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on July 16, 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.