ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE

ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE is an FDA 510(k)-cleared medical device (K884262) 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 December 20, 1988. Regulation: 8.