FLEXMEDICS GUIDEWIRE .012 ONLY

FLEXMEDICS GUIDEWIRE .012 ONLY is an FDA 510(k)-cleared medical device (K895899) manufactured by Flexmedics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 1990. Regulation: 8.