NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE

NAVIGUIDE HYDROPHILIC COATED GUIDEWIRE is an FDA 510(k)-cleared medical device (K922674) 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 December 20, 1992. Regulation: 8.