VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)

VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) is an FDA 510(k)-cleared medical device (K944004) manufactured by Endosonics Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1995. Regulation: 8.