ANGIOMAT ILLUMENA

ANGIOMAT ILLUMENA is an FDA 510(k)-cleared medical device (K963071) manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 1997. Regulation: 8.