LOW PROFILE STEERABLE BALLOON DILATION

LOW PROFILE STEERABLE BALLOON DILATION is an FDA 510(k)-cleared medical device (K843880) manufactured by Advanced Cardiovascular Systems, 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 November 26, 1984. Regulation: 8.