OPTICALLY CLEAR RADIOPAQUE CATHETER

OPTICALLY CLEAR RADIOPAQUE CATHETER is an FDA 510(k)-cleared medical device (K893546) manufactured by Critikon Company, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 31, 1989. Regulation: 8.