Reprocessed ViewFlex Xtra ICE Catheter

Reprocessed ViewFlex Xtra ICE Catheter is an FDA 510(k)-cleared medical device (K182238) manufactured by Stryker Sustainability Solutions. 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 7, 2019. Regulation: 8.