ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO

ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO is an FDA 510(k)-cleared medical device (K851854) 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 August 4, 1985. Regulation: 8.