BD POSIFLOW POSITIVE DISPLACEMENT VALVE

About This 510(k) Submission

K050207 is an FDA 510(k) clearance for the BD POSIFLOW POSITIVE DISPLACEMENT VALVE, 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 7, 2005, 69 days after receiving the submission on January 28, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.