Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula

Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula is an FDA 510(k)-cleared medical device (K200358) manufactured by Edwards Lifesciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2020. Regulation: 8.