GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER

GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER is an FDA 510(k)-cleared medical device (K903606) manufactured by North American Instrument 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 September 26, 1990. Regulation: 8.