NEXIVA CLOSED IV CATHETER SYSTEM

About This 510(k) Submission

K032843 is an FDA 510(k) clearance for the NEXIVA CLOSED IV CATHETER SYSTEM, 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 February 27, 2004, 169 days after receiving the submission on September 11, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.