510(k) K151791

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTZ

K151791 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 Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir". The FDA issued a decision of Substantially Equivalent on November 19, 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.