SARNS HIGH FLOW AORTIC ARCH CANNULA

SARNS HIGH FLOW AORTIC ARCH CANNULA is an FDA 510(k)-cleared medical device (K133151) manufactured by Terumo Cardiovascular Systems Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 2014. Regulation: 8.