AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT

AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT is an FDA 510(k)-cleared medical device (K842113) manufactured by Mallinckrodt Critical Care. 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 12, 1984. Regulation: 8.