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Nexiva Closed IV Catheter System with NearPort IV Access

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231239

by Becton Dickinson Infusion Therapy Systems Inc.

Identifiers

510(k) Number
K231239 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nexiva Closed IV Catheter System with NearPort IV Access is an all-in-one peripheral intravenous catheter system. It is intended for insertion into a patient's peripheral venous system for short-term use to administer fluids, deliver medications, and sample blood.

This device is supplied for clinical use and is authorized under FDA 510K clearance. It is designed to be used as a peripheral IV catheter system for the administration of fluids and medications.

Frequently asked questions

What is the primary clinical purpose of the Nexiva Closed IV Catheter System?

This device is an all-in-one peripheral intravenous catheter system designed for short-term use. It is indicated for insertion into a patient's peripheral venous system to facilitate the administration of fluids, the delivery of medications, and the sampling of blood.

What is the regulatory status of this catheter system?

The Nexiva Closed IV Catheter System with NearPort IV Access is authorized under FDA 510K clearance, identified by K-number K231239. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

Who is the manufacturer of the Nexiva Closed IV Catheter System?

The device is manufactured by Becton Dickinson Infusion Therapy Systems, Inc., located in Sandy, Utah. The company manages the production and regulatory filings for this specific peripheral IV catheter system.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Nexiva™ Catheter System, Nexiva™ Closed IV Catheter System with NearPort™ IV Access (K231239 ..., BD Nexiva™, PDF BD Nexiva™ Closed IV Catheter Syst - res.onemed.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.
FDA Applicant
Becton Dickinson Infusion Therapy Systems, Inc.

Sources (1)

  • FDA 510(k) K231239 24 fields · synced Oct 6, 2026