BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

About This 510(k) Submission

K161777 is an FDA 510(k) clearance for the BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on August 29, 2016, 61 days after receiving the submission on June 29, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.