NOVAGOLD HIGH PERFORMANCE GUIDEWIRE

NOVAGOLD HIGH PERFORMANCE GUIDEWIRE is an FDA 510(k)-cleared medical device (K133076) manufactured by Neometrics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2014. Regulation: 8.