LOW PROFILE STEERABLE BALLOON DILATA

LOW PROFILE STEERABLE BALLOON DILATA is an FDA 510(k)-cleared medical device (K831403) 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 June 7, 1983. Regulation: 8.