HI-TORQUE BALANCE TREK GUIDE WIRE

HI-TORQUE BALANCE TREK GUIDE WIRE is an FDA 510(k)-cleared medical device (K991152) manufactured by Guidant Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 1999. Regulation: 8.