BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100

About This 510(k) Submission

K013621 is an FDA 510(k) clearance for the BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on April 16, 2002, 162 days after receiving the submission on November 5, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.