ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE is an FDA 510(k)-cleared medical device (K130766) manufactured by Cook, 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 July 16, 2013. Regulation: 8.