NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM is an FDA 510(k)-cleared medical device (K901263) manufactured by Navion Biomedical Corp.. 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 August 21, 1990. Regulation: 8.