ViewFlex Xtra ICE Catheter

ViewFlex Xtra ICE Catheter is an FDA 510(k)-cleared medical device (K223077) manufactured by Irvine Biomedical, A St. Jude Medical Company. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2022. Regulation: 8.