THE PILOT SCIMED TORQUE DEVICE

THE PILOT SCIMED TORQUE DEVICE is an FDA 510(k)-cleared medical device (K896108) manufactured by Scimed Life 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 January 8, 1990. Regulation: 8.