.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP

.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP is an FDA 510(k)-cleared medical device (K905502) 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 3, 1991. Regulation: 8.