NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 is an FDA 510(k)-cleared medical device (K101194) 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 July 10, 2011. Regulation: 8.