Volcano Visions PV .018 Digital IVUS Catheter

Volcano Visions PV .018 Digital IVUS Catheter is an FDA 510(k)-cleared medical device (K150442) 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 September 3, 2015. Regulation: 8.