Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter is an FDA 510(k)-cleared medical device (K253399) manufactured by Volcano Corporation (Dba Philips Image Guided Therapy Device. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2025. Regulation: 8.