SARNS SOFT-FLOW EXTENDED AORTIC CANNULA

SARNS SOFT-FLOW EXTENDED AORTIC CANNULA is an FDA 510(k)-cleared medical device (K132811) 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 February 26, 2014. Regulation: 8.