CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 is an FDA 510(k)-cleared medical device (K911384) manufactured by Endosonics 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 June 24, 1991. Regulation: 8.