.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE

.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE is an FDA 510(k)-cleared medical device (K915723) 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 June 8, 1992. Regulation: 8.