CRITIKON TRIPLE-LUMEN CENTRAL VENOUS

CRITIKON TRIPLE-LUMEN CENTRAL VENOUS is an FDA 510(k)-cleared medical device (K842316) manufactured by Critikon Company, 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 July 19, 1984. Regulation: 8.