510(k) K161777

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code FOZ

K161777 is an FDA 510(k) premarket notification submitted by Becton Dickinson Infusion Therapy Systems, Inc. for the device "BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems". The FDA issued a decision of Substantially Equivalent on August 29, 2016. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Becton Dickinson Infusion Therapy Systems, Inc. has at least 10 other 510(k) clearances on record.