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Velano ExT Extension Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200439

by Velano Vascular

Identifiers

510(k) Number
K200439 FDA 510(k)
FDA Product Code
FPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5440 FDA 510(k)
Regulation Number
880.5440 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Velano ExT Extension Set is an Intravascular Administration Set (Product Code FPA), designed for intravenous fluid administration. It features a 5-inch PVC tubing with a T-connection port, needle-free connector, and a female luer lock, ensuring compatibility with intravenous lines while minimizing contamination risk.

This sterile, single-use device includes an integrated stabilizer for secure anchoring to the patient. Supplied non-pyrogenic and intended for hospital use, it adheres to regulatory standards under 21 CFR 880.5440. The device holds FDA 510(k) clearance (K200439) for substantial equivalence in the General Hospital category.

Frequently asked questions

What types of intravenous lines is the Velano ExT Extension Set compatible with, and how does it help reduce contamination risk?

The Velano ExT Extension Set is designed for compatibility with standard intravenous lines due to its female luer lock connector. It includes a needle-free connector, which eliminates the need for needles or sharp devices at the connection point, thereby significantly reducing the risk of contamination and needlestick injuries during fluid administration.

Is the Velano ExT Extension Set meant for repeated use, or is it intended to be used only once and then discarded?

The Velano ExT Extension Set is explicitly labeled as a single-use device. This designation ensures patient safety by preventing potential contamination from reuse, which is a common practice for sterile medical devices like this one.

What is the length of the tubing in the Velano ExT Extension Set, and how does the integrated stabilizer benefit the patient?

The tubing in the Velano ExT Extension Set is 5 inches long, providing a flexible length for positioning while maintaining secure attachment. The integrated stabilizer ensures the set remains anchored securely to the patient, reducing the risk of accidental dislodgment during use, which is particularly important for continuous intravenous therapy.

How should the Velano ExT Extension Set be stored, and what does the non-pyrogenic designation mean for hospital use?

The Velano ExT Extension Set should be stored according to standard sterile medical device protocols, typically in a clean, dry environment away from direct sunlight or extreme temperatures. The non-pyrogenic designation means the device is manufactured to avoid introducing fever-inducing substances (pyrogens) into the patient’s bloodstream, which is critical for safe intravenous administration in hospital settings.

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: Velano ExT Extension Set (K200439) — FDA 510 (k) | Innolitics, K200439 FDA 510(k) - Velano ExT Extension Set | Velano Vascular, PDF Velano Vascular Tiffini Wittwer Consulting Director Regulatory Affairs ..., Velano ExT Extension Set (K200439) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Velano Vascular

Sources (1)

  • FDA 510(k) K200439 24 fields · synced Sep 19, 2026