NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) is an FDA 510(k)-cleared medical device (K120830) manufactured by Carticept Medical, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 2012. Regulation: 8.