Glidesheath Slender Tibial Pedal Kit

Glidesheath Slender Tibial Pedal Kit is an FDA 510(k)-cleared medical device (K181237) manufactured by Terumo Medical Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2018. Regulation: 8.