ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO

ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO is an FDA 510(k)-cleared medical device (K853746) 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 October 20, 1985. Regulation: 8.