VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)

VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) is an FDA 510(k)-cleared medical device (K982329) 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 January 13, 1999. Regulation: 8.