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FDA 510(k)

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

K-Number: K161777 · 2016-08-29

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date2016-08-29
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems is a medical device manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2016-08-29 under approval number K161777. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems?

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems is a medical device that received FDA 510(k) clearance on 2016-08-29. It is manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K161777.

When was BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems approved by the FDA?

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems received FDA 510(k) clearance on 2016-08-29, under approval number K161777.

What company makes BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems?

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems is manufactured by Becton Dickinson Infusion Therapy Systems, Inc..

What is the FDA product code for BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems?

The FDA product code for BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems is FOZ.

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Other Devices by Becton Dickinson Infusion Therapy Systems, Inc.

K173354BD Nexiva Diffusics Closed IV Catheter Systems K183399BD Nexiva Closed IV Catheter System K201717BD Cathena Safety IV Catheter K192493BD Cathena (TM) Safety IV Catheter K220584BD Cathena Safety IV Catheter K233529BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

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Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd. K160235ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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