Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is an FDA 510(k)-cleared medical device (K210655) 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 May 24, 2022. Regulation: 8.