Visions PV.014P RX Digital IVUS Catheter

Visions PV.014P RX Digital IVUS Catheter is an FDA 510(k)-cleared medical device (K152829) manufactured by Volcano Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2015. Regulation: 8.