BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100

BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 is an FDA 510(k)-cleared medical device (K013621) 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 15, 2002. Regulation: 8.