CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE

CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE is an FDA 510(k)-cleared medical device (K884481) manufactured by Mallinckroot, Inc.. 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 9, 1989. Regulation: 8.