MODIFICATION TO ACS CORONARY GUIDING

MODIFICATION TO ACS CORONARY GUIDING is an FDA 510(k)-cleared medical device (K841992) manufactured by Advanced Cardiovascular Systems, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 1984. Regulation: 8.