BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170336 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 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector is a closed-system intravenous catheter designed to reduce the risk of contamination and catheter failure during intravenous therapy. It integrates a single-port catheter with a MaxZero needleless connector, combining stabilization, pre-attached extension tubing, and a proprietary biomaterial to enhance reliability and usability. This system is classified under the General Hospital device category and is intended for peripheral venous access in clinical settings.
The device is supplied as a sterile, single-use product, intended for one-time use in hospital environments. It is compatible with standard intravenous administration setups and is engineered for MRI safety, as indicated by its design specifications. Storage requires protection from extreme temperatures and direct light, adhering to standard medical device handling protocols. The system holds FDA 510K clearance (K170336) under the Traditional review pathway, ensuring compliance with regulatory standards for intravenous catheters.
Frequently asked questions
What is the primary purpose of the BD Nexiva Closed IV Catheter System with MaxZero Needleless Connector, and how does it differ from traditional IV catheters?
The BD Nexiva Closed IV Catheter System (Single Port) is designed specifically to reduce contamination risks and catheter failure during intravenous therapy. Unlike traditional IV catheters, it combines a single-port catheter with a MaxZero needleless connector, pre-attached extension tubing, and a proprietary biomaterial to improve stability and reliability. This closed-system design helps minimize exposure to pathogens, which is particularly useful in clinical settings where infection control is critical.
Is this device intended for reuse, or is it meant for single-use only? How should it be stored?
The BD Nexiva Closed IV Catheter System is explicitly labeled as a sterile, single-use product, meaning it should only be used once per patient. Storage requires protection from extreme temperatures and direct light, following standard medical device handling protocols to maintain its integrity and sterility.
What types of clinical settings is this catheter system approved for, and does it work with standard IV administration setups?
The system is classified under the General Hospital device category and is intended for peripheral venous access in hospital environments. It is engineered to be compatible with standard intravenous administration setups, ensuring seamless integration into existing clinical workflows.
Does this catheter system have any special considerations for imaging procedures, such as MRI?
Yes, the BD Nexiva Closed IV Catheter System is designed with MRI safety in mind, as indicated in its specifications. This means it can be used in patients who require MRI imaging without posing additional risks related to the catheter itself.
How can I verify the regulatory compliance of this device?
The device holds FDA 510K clearance (K170336) under the Traditional review pathway, confirming it meets regulatory standards for intravenous catheters. The clearance was granted by the FDA’s Orthopaedics and Rehabilitation Devices Panel (HO), ensuring compliance with U.S. medical device regulations.
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, Becton Dickinson – Wikipedia, BD Nexiva™ Closed IV Catheter System—single port with BD MaxZero ..., BD Nexiva Closed IV Catheter System - Single Port with BD Maxzero ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170336 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K170336 24 fields · synced Sep 20, 2026