Reconnaissance PV .018 OTW Digital IVUS Catheter

Reconnaissance PV .018 OTW Digital IVUS Catheter is an FDA 510(k)-cleared medical device (K200410) manufactured by Philips Image Guided Therapy 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 May 21, 2020. Regulation: 8.