NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is an FDA 510(k)-cleared medical device (K250592) manufactured by Northeast Scientific, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2025. Regulation: 8.