BD Nexiva Diffusics Closed IV Catheter System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170283 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 Diffusics Closed IV Catheter System is a closed intravenous catheter designed for peripheral venous access. Its diffusion tip features three laser-cut teardrop holes around the catheter tip, enabling high-flow and power-injection protocols up to 325 psi while maintaining a sealed system to reduce contamination risk.
This system is intended for single-use in hospital settings and is supplied sterile. It is classified under product code FOZ and holds FDA 510(k) clearance as substantially equivalent to a predicate device. The catheter is reusable only as specified by the manufacturer’s instructions for decontamination and reprocessing, if applicable, though standard practice for this product remains single-use.
Frequently asked questions
What makes the BD Nexiva Diffusics Closed IV Catheter System different from standard IV catheters in terms of flow and safety?
The BD Nexiva Diffusics system features a diffusion tip with three laser-cut teardrop holes, allowing it to support high-flow and power-injection protocols up to 325 psi—far exceeding typical IV catheters. Its closed-system design also minimizes contamination risk by maintaining a sealed pathway during use, which is particularly useful in hospital settings where infection control is critical.
Is this catheter intended for repeated use, or is it meant to be used only once?
The BD Nexiva Diffusics Closed IV Catheter System is primarily intended for single-use, as is standard practice for most IV catheters. While the manufacturer’s instructions *technically* allow for reprocessing under specific decontamination protocols, clinical guidelines and common practice strongly recommend disposable use only to ensure sterility and patient safety.
How is the BD Nexiva Diffusics system supplied, and what should I check before using it?
The system is supplied sterile and ready for immediate use in hospital settings. Before use, verify the sterility seal is intact and inspect the catheter for any visible damage. Since it’s a closed system, ensure the diffusion tip and connector integrity are maintained to prevent contamination during infusion.
What types of medical facilities or departments would benefit most from this catheter system?
This system is particularly useful in general hospital settings, especially in departments requiring high-flow or power-injection protocols, such as radiology (for contrast studies), emergency care, or critical care units. Its closed-system design also aligns with infection control protocols in high-turnover or sterile environments.
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™ Diffusics™ closed IV catheter system | BD, BD Nexiva™ Closed IV Catheter System, BD Nexiva™, BD (company) - Wikipedia, BD Nexiva™ Diffusics™ closed IV catheter system | BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170283 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K170283 24 fields · synced Sep 18, 2026