Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is an FDA 510(k)-cleared medical device (K151389) manufactured by Terumo Cardiovascular Systems Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 2015. Regulation: 8.