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Leaderflex

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141026

by Vygon

Identifiers

510(k) Number
K141026 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 Leaderflex is a single-lumen central venous catheter (CVC) designed for venous access, constructed from radiopaque polyurethane. It features fixation wings and an integral extension tube, available in sizes 22G (2 Fr) and 20G/18G (3 Fr/4 Fr), with dwell lengths of 4.4 cm (standard) or 9.8 cm (codes 1212.20/205). The catheter is thermosensitive and suitable for extended-dwell peripheral or central venous applications via the Seldinger technique.

The Leaderflex is supplied sterile, with optional straight guidewire compatibility, and includes a puncture needle and Luer-lock hub for secure access. It is intended for single-use in hospital settings, including general medical and pediatric care. The device is FDA-cleared under 510(k) K141026 (FOZ classification) and adheres to standard sterile barrier packaging for clinical use.

Frequently asked questions

What is the Leaderflex catheter designed for?

The Leaderflex is a single-lumen central venous catheter (CVC) designed for venous access in hospital settings, including general medical and pediatric care. Its radiopaque polyurethane construction allows for real-time X-ray visualization during insertion, reducing the risk of misplacement. The catheter is suitable for both peripheral and central venous applications using the Seldinger technique, enabling precise placement via a guidewire.

What sizes and dwell lengths are available for the Leaderflex?

The Leaderflex comes in three gauge sizes: 22G (2 Fr), 20G (3 Fr), and 18G (4 Fr). Dwell lengths vary by size, with a standard length of 4.4 cm for all gauges and an extended length of 9.8 cm available for the 20G (3 Fr) and 18G (4 Fr) models (codes 1212.20 and 205, respectively). This flexibility accommodates different patient anatomies and procedural needs.

Is the Leaderflex compatible with straight guidewires?

Yes, the Leaderflex is designed with optional straight guidewire compatibility. This feature simplifies the Seldinger technique by allowing clinicians to use a straight guidewire for catheter insertion, which may be particularly useful in pediatric or challenging anatomical cases where flexibility is less critical.

How is the Leaderflex supplied and what does the packaging include?

The Leaderflex is supplied sterile in standard sterile barrier packaging, ensuring clinical readiness upon opening. Each kit includes a puncture needle and a Luer-lock hub for secure intravenous access. The integral extension tube and fixation wings are also part of the sterile assembly, eliminating the need for additional connectors or securing devices.

Can the Leaderflex be reused, or is it intended for single-use?

The Leaderflex is explicitly intended for single-use only. Its polyurethane construction, combined with sterile packaging and design features like the integral extension tube and fixation wings, is optimized for one-time clinical use. Reuse is not recommended due to potential contamination risks and degradation of materials over time.

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: Leaderflex 22G - 2 Fr - Single lumen CVC | Vygon, Leaderflex 22G - 2 Fr - Single lumen CVC | Vygon USA, Leaderflex - Vygon, Leaderflex 20G - 3 Fr / 18G - 4 Fr - Single lumen CVC | Vygon

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vygon

Sources (1)

  • FDA 510(k) K141026 24 fields · synced Oct 1, 2026