EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE is an FDA 510(k)-cleared medical device (K033542) manufactured by Galt Medical 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 4, 2003. Regulation: 8.