FEM-FLEX FEMORAL ACCESS CANNULATION SET

FEM-FLEX FEMORAL ACCESS CANNULATION SET is an FDA 510(k)-cleared medical device (K891576) manufactured by Research Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 1989. Regulation: 8.