ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE

ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE is an FDA 510(k)-cleared medical device (K950156) 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 April 4, 1995. Regulation: 8.