← Back to catalogue

Amplatzer Vascular Plug II Models AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071125

by Aga Medical Corp.

Identifiers

510(k) Number
K071125 FDA 510(k)
FDA Product Code
KRD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3300 FDA 510(k)
Regulation Number
870.3300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Amplatzer Vascular Plug II is a self-expanding, metallic endovascular device designed for vascular embolization. It is classified as a vascular occlusion device and functions by occluding blood vessels to stop blood flow, typically used in interventional radiology and cardiology procedures. The device is constructed to conform to the vessel walls upon deployment, providing a reliable seal for embolization purposes.

The Amplatzer Vascular Plug II is supplied as a sterile, single-use device and is intended for use in controlled clinical settings such as catheterization labs. Available in multiple sizes (AVP2-004 through AVP2-016), it is selected based on vessel diameter to ensure proper occlusion. The device has received FDA 510(k) clearance under the Special 510(k) Review pathway and is regulated under the classification for vascular embolization devices. Storage and handling follow standard sterile medical device protocols.

Frequently asked questions

What is the Amplatzer Vascular Plug II used for?

The Amplatzer Vascular Plug II is a self-expanding, metallic endovascular device designed specifically for vascular embolization. It works by occluding blood vessels to stop blood flow, which is commonly used in interventional radiology and cardiology procedures. This helps treat conditions like arteriovenous malformations, aneurysms, or other vascular abnormalities where controlling blood flow is critical.

How is the Amplatzer Vascular Plug II supplied and what are its key features?

The Amplatzer Vascular Plug II is supplied as a sterile, single-use device, ensuring safety and reliability for controlled clinical settings like catheterization labs. It is constructed from metallic material that expands upon deployment, conforming tightly to the vessel walls to create a secure seal. The device is available in multiple sizes (AVP2-004 through AVP2-016), allowing clinicians to select the appropriate size based on the vessel diameter for optimal occlusion.

Is the Amplatzer Vascular Plug II reusable or single-use, and how should it be stored?

The Amplatzer Vascular Plug II is designed for single-use only, adhering to standard sterile medical device protocols. This ensures patient safety and prevents cross-contamination. Storage should follow sterile medical device guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

What sizes are available for the Amplatzer Vascular Plug II, and how are they selected?

The Amplatzer Vascular Plug II comes in six sizes: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, and AVP2-016. The size is selected based on the diameter of the vessel to be occluded, ensuring a proper fit and effective embolization. Pre-procedure imaging, such as angiography, is typically used to measure the vessel diameter and guide size selection.

What regulatory pathway does the Amplatzer Vascular Plug II follow?

The Amplatzer Vascular Plug II has received FDA 510(k) clearance under the Special 510(k) Review pathway, specifically under the classification for vascular embolization devices. This pathway ensures that the device meets regulatory standards for safety and effectiveness as determined by the FDA’s review process, particularly through the Cardiovascular Advisory Committee.

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: Amplatzer Vascular Plug II (AVP II) - Ordering Information | Abbott, Amplatzer Vascular Plug II (AVP II) - Sizing and Specs | Abbott, Amplatzer Vascular Plug Ii Models: Avp2-004, Avp2-006, Avp2-008, Avp2 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aga Medical Corp.

Sources (1)

  • FDA 510(k) K071125 24 fields · synced Oct 1, 2026