NAVIGUIDE HYDROPHILIC GUIDE WIRE

NAVIGUIDE HYDROPHILIC GUIDE WIRE is an FDA 510(k)-cleared medical device (K943358) manufactured by Meadox Medicals, Div. Boston Scientific 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 June 1, 1995. Regulation: 8.