INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

INSYTE CATHETER, INSYTE AUTOGUARD CATHETER is an FDA 510(k)-cleared medical device (K000235) manufactured by Becton Dickinson Infusion Therapy Systems, 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 4, 2000. Regulation: 8.