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AMPLATZER VASCULAR PLUG II - Avp2-022

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071699

by Aga Medical Corp.

Identifiers

510(k) Number
K071699 FDA 510(k)
FDA Product Code
KRD FDA 510(k)
Models / Variants
Avp2-003 FDA 510(k)
Avp2-018 FDA 510(k)
Avp2-020 FDA 510(k)
Avp2-022 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 device made from a Nitinol wire mesh, which provides rapid embolization and can adjust to variable landing zones. It is indicated for arterial and venous embolizations in the peripheral vasculature.

The device is supplied in models AVP2-003, AVP2-018, AVP2-020, and AVP2-022. It received FDA 510(k) clearance (K071699) on August 15, 2007, and is classified under product code KRD with regulation number 870.3300. The device is used in cardiovascular procedures.

Frequently asked questions

What is the Amplatzer Vascular Plug II used for?

The Amplatzer Vascular Plug II is indicated for arterial and venous embolizations in the peripheral vasculature, providing rapid embolization and the ability to adjust to variable landing zones due to its Nitinol wire mesh construction.

How is the Amplatzer Vascular Plug II supplied and what models are available?

The device is supplied in four specific models: AVP2-003, AVP2-018, AVP2-020, and AVP2-022, each differing in size to accommodate various vessel diameters during peripheral embolization procedures.

Is the Amplatzer Vascular Plug II made from Nitinol and how does this material affect its function?

Yes, the device is made from a Nitinol wire mesh, which allows it to self-expand, conform to irregular vessel shapes, and maintain stability in variable landing zones while enabling rapid embolization.

What regulatory pathway was used for the Amplatzer Vascular Plug II and when was it cleared?

The Amplatzer Vascular Plug II received FDA 510(k) clearance under submission K071699 on August 15, 2007, and is classified as a Class II device under product code KRD and regulation number 870.3300.

Can the Amplatzer Vascular Plug II be used in both arteries and veins for embolization?

Yes, the device is indicated for use in both arterial and venous embolization within the peripheral vasculature, making it suitable for a range of vascular occlusion procedures in veins and arteries.

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 Family of Vascular Plugs - AVP II | Abbott, Amplatzer Vascular Plug II (AVP II) - Ordering Information | Abbott, PDF Vascular Plug II - manuals.eifu.abbott, Amplatzer Vascular Plug Ii, Models Avp2-003, Avp2-018, Avp2-020, Avp2 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aga Medical Corp.

Sources (1)

  • FDA 510(k) K071699 24 fields · synced Oct 6, 2026