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ARRAVASC LIMITED

US

Last updated May 24, 2026

What ARRAVASC LIMITED makes

Arravasc Limited manufactures peripheral angioplasty balloon catheters designed for basic vascular interventions, including dilation of narrowed or obstructed arteries in peripheral blood vessels.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Arravasc Limited is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Arravasc Limited manufacture?

Arravasc Limited specializes in peripheral angioplasty balloon catheters, which are used for basic vascular interventions. These devices are primarily designed to dilate narrowed or obstructed arteries in peripheral blood vessels, helping to restore blood flow in areas like the legs or arms.

Where is Arravasc Limited based?

Arravasc Limited is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance with U.S. medical device regulations.

Which regulatory registries list Arravasc Limited’s devices?

Arravasc Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers and regulatory bodies tracking medical devices.

How are Arravasc Limited’s devices classified under FDA regulations?

Arravasc Limited’s peripheral angioplasty balloon catheters fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

Why are Arravasc Limited’s devices listed in the FDA’s UDI database?

The FDA’s UDI database includes Arravasc Limited’s devices to improve patient safety and regulatory oversight. UDIs provide a standardized way to identify medical devices throughout their lifecycle, reducing errors in ordering, labeling, and tracking—critical for devices like angioplasty catheters used in vascular procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
arravasc.com
LinkedIn
—
Facebook
—
Phone
+353091758939
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
896165250

Catalogue (446)

Page 9 of 9
DeviceModel / ReferenceRegistriesClassStatus
Advocate A14030060150
FDA UDI
Class IIActive
Advocate A18060250150
FDA UDI
Class IIActive
Advocate A18025250150
FDA UDI
Class IIActive
Advocate A18025200130
FDA UDI
Class IIActive
Advocate A18025080130
FDA UDI
Class IIActive
Advocate A14030100130
FDA UDI
Class IIActive
Advocate A14035060130
FDA UDI
Class IIActive
Advocate A35100080075
FDA UDI
Class IIActive
Advocate A14025200090
FDA UDI
Class IIActive
Advocate A18020080090
FDA UDI
Class IIActive
Advocate A18090040090
FDA UDI
Class IIActive
Advocate A18060250130
FDA UDI
Class IIActive
Advocate A18060250090
FDA UDI
Class IIActive
Advocate A35060200130
FDA UDI
Class IIActive
Advocate A18025150150
FDA UDI
Class IIActive
Advocate A14035150150
FDA UDI
Class IIActive
Advocate A18020060150
FDA UDI
Class IIActive
Advocate A14025300130
FDA UDI
Class IIActive
Advocate A18050150150
FDA UDI
Class IIActive
Advocate A14040080150
FDA UDI
Class IIActive
Advocate A18040200150
FDA UDI
Class IIActive
Advocate A18030300130
FDA UDI
Class IIActive
Advocate A18030080130
FDA UDI
Class IIActive
Advocate A18030040150
FDA UDI
Class IIActive
Advocate A35060020075
FDA UDI
Class IIActive
Advocate A18070250150
FDA UDI
Class IIActive
Advocate A35050040130
FDA UDI
Class IIActive
Advocate A14030080090
FDA UDI
Class IIActive
Advocate A14030150090
FDA UDI
Class IIActive
Advocate A18040200130
FDA UDI
Class IIActive
Advocate A14040200090
FDA UDI
Class IIActive
Advocate A35060100130
FDA UDI
Class IIActive
Advocate A35070080075
FDA UDI
Class IIActive
Advocate A18020060090
FDA UDI
Class IIActive
Advocate A35050150130
FDA UDI
Class IIActive
Advocate A14025060090
FDA UDI
Class IIActive
Advocate A14030015130
FDA UDI
Class IIActive
Advocate A35040080075
FDA UDI
Class IIActive
Advocate A14020060150
FDA UDI
Class IIActive
Advocate A18050250090
FDA UDI
Class IIActive
Advocate A18090100090
FDA UDI
Class IIActive
Advocate A14040060090
FDA UDI
Class IIActive
Pirouette 018 K151153
FDA 510(k)
Class IIActive
Pirouette 014 K162316
FDA 510(k)
Class IIActive
Pirouette High Pressure (HP) K172033
FDA 510(k)
Class IIActive
Pirouette 035 K161427
FDA 510(k)
Class IIActive

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