ACS ANGIOTRAK(TM) SYSTEM

ACS ANGIOTRAK(TM) SYSTEM is an FDA 510(k)-cleared medical device (K921719) 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 6, 1992. Regulation: 8.