Reprocessed Visions PV .035 Digital IVUS Catheter

Reprocessed Visions PV .035 Digital IVUS Catheter is an FDA 510(k)-cleared medical device (K181126) manufactured by Innovative Health, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 2019. Regulation: 8.