CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM

CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K062265) manufactured by Swiss Medical Care S.A.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 25, 2006. Regulation: 8.