INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS

INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS is an FDA 510(k)-cleared medical device (K971339) manufactured by Becton Dickinson Vascular Access, 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 December 23, 1997. Regulation: 8.