RADIUS NEXT GENERATION GUIDEWIRE

RADIUS NEXT GENERATION GUIDEWIRE is an FDA 510(k)-cleared medical device (K011759) manufactured by Radius Medical Technologies, 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 August 22, 2001. Regulation: 8.