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400um Perforator and Accessory Vein Ablation Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181044

by Angiodynamics, Inc.

Identifiers

510(k) Number
K181044 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Perforator and Accessory Vein Ablation Kit, designed for the treatment of venous insufficiency. It combines a 400 µm perforator probe with accessory components to facilitate endovenous laser ablation (EVLA) of perforating veins and accessory veins, aiding in the closure of incompetent venous segments. The kit is intended for use in minimally invasive procedures to address varicose veins and related conditions. Its primary function is to deliver controlled thermal energy to seal abnormal venous pathways while preserving surrounding tissue integrity.

The kit is supplied as a single-use, sterile device intended for use in clinical settings by trained healthcare professionals. It includes a 400 µm perforator probe and associated accessories for precise vein access and ablation. The device is classified under product code GEX and has received FDA 510(k) clearance under the Traditional review pathway, with a decision date of July 5, 2018. No specific MRI safety or reusable components are indicated in the specifications.

Frequently asked questions

What is the 400 µm Perforator and Accessory Vein Ablation Kit used for?

This kit is designed specifically for endovenous laser ablation (EVLA) of perforating veins and accessory veins, which are often involved in venous insufficiency and varicose veins. The 400 µm perforator probe delivers controlled thermal energy to seal incompetent venous segments while minimizing damage to surrounding tissue, making it ideal for minimally invasive procedures targeting abnormal venous pathways.

Is the 400 µm Perforator Ablation Kit single-use or reusable?

The kit is intended for single-use only. It is supplied sterile to ensure patient safety and procedural consistency, requiring a new kit for each patient procedure. Reuse is not recommended or indicated by the manufacturer.

What components does the kit include for vein access and ablation?

The kit combines a 400 µm perforator probe with accessory components tailored for precise vein access and ablation. These accessories are designed to work together with the probe to facilitate accurate delivery of laser energy, ensuring effective closure of targeted venous segments during EVLA procedures.

How should the 400 µm Perforator Ablation Kit be stored?

The kit should be stored in its original, unopened packaging in a clean, dry environment protected from direct sunlight and extreme temperatures. Ensure the sterile barrier remains intact until immediate use to maintain sterility and prevent contamination.

Does this kit have any reusable parts or components?

No reusable components are indicated for this kit. All parts, including the 400 µm perforator probe and accessories, are intended for single-use only to uphold sterility and procedural safety standards.

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: 400 Micron Perforator & Accessory Vein Ablation Kit (PVAK), The VenaCure EVLT System | AngioDynamics, 400 Micron Perforator & Accessory Vein Ablation Kit (PVAK)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA 510(k) K181044 24 fields · synced Oct 1, 2026