FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET

FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET is an FDA 510(k)-cleared medical device (K132592) manufactured by Cook, 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 8, 2014. Regulation: 8.