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FDA 510(k)

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems

K-Number: K161777 · 2016-08-29

Decision Date2016-08-29
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) 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. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K161777.

When did BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Becton Dickinson Infusion Therapy Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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