XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL

XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL is an FDA 510(k)-cleared medical device (K013473) manufactured by Xtrak Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2002. Regulation: 8.