Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter

Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter is an FDA 510(k)-cleared medical device (K202042) 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 November 19, 2020. Regulation: 8.