MERIT LAUREATE HYDROPHILIC GUIDE WIRE

MERIT LAUREATE HYDROPHILIC GUIDE WIRE is an FDA 510(k)-cleared medical device (K092303) manufactured by Merit Medical 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 October 26, 2009. Regulation: 8.