GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET

GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET is an FDA 510(k)-cleared medical device (K030467) manufactured by Iv 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 March 13, 2003. Regulation: 8.