VIEWFLEX XTRA ICE CATHETER

VIEWFLEX XTRA ICE CATHETER is an FDA 510(k)-cleared medical device (K133853) manufactured by Irvine Biomedical, Inc., 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 May 18, 2014. Regulation: 8.