510(k) K130520

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR by Ashitaka Factory Of Terumo Corp. — Product Code DTZ

K130520 is an FDA 510(k) premarket notification submitted by Ashitaka Factory Of Terumo Corp. for the device "CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR". The FDA issued a decision of Substantially Equivalent on Mar 13, 2013. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Ashitaka Factory Of Terumo Corp. has 2 other 510(k) clearances on record.