Capiox Advance Hardshell Reservoir

Capiox Advance Hardshell Reservoir is an FDA 510(k)-cleared medical device (K153143) 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 December 1, 2015. Regulation: 8.