Roadrunner PC Wire Guide, Olcott Torque Device

Roadrunner PC Wire Guide, Olcott Torque Device is an FDA 510(k)-cleared medical device (K182985) manufactured by Cook Incorporated. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2019. Regulation: 8.