510(k) K130493

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR by Terumo Corporation — Product Code DTZ

K130493 is an FDA 510(k) premarket notification submitted by Terumo Corporation for the device "CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR". The FDA issued a decision of Substantially Equivalent on March 13, 2013. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Terumo Corporation has at least 10 other 510(k) clearances on record.