OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE

OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE is an FDA 510(k)-cleared medical device (K140185) manufactured by Avinger, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2014. Regulation: 8.