CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE

CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE is an FDA 510(k)-cleared medical device (K062727) manufactured by Medtronic Vascular. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2006. Regulation: 8.