ANGIOMAT 3000, 6000, CT INJECTOR

ANGIOMAT 3000, 6000, CT INJECTOR is an FDA 510(k)-cleared medical device (K944875) manufactured by Lievel-Flarsheim Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 1995. Regulation: 8.