510(k) K153213

Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTZ

K153213 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir". The FDA issued a decision of Substantially Equivalent on December 3, 2015. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.