ACS HI-TORQUE BALANCE(TM) GUIDE WIRE

ACS HI-TORQUE BALANCE(TM) GUIDE WIRE is an FDA 510(k)-cleared medical device (K925381) 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 February 11, 1993. Regulation: 8.