510(k) K151389

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTZ

K151389 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir". The FDA issued a decision of Substantially Equivalent on October 20, 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.