Capiox iCP Centrifugal Pump

Capiox iCP Centrifugal Pump is an FDA 510(k)-cleared medical device (K200091) 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 November 17, 2021. Regulation: 8.