ACS HI-TORQUE IRON MAN GUIDE WIRE

ACS HI-TORQUE IRON MAN GUIDE WIRE is an FDA 510(k)-cleared medical device (K963702) 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 January 21, 1997. Regulation: 8.