ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH

ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH is an FDA 510(k)-cleared medical device (K926421) 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 March 22, 1993. Regulation: 8.