Angioplasty balloons

Amphirion Plus

by Medtronic, Inc.

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

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Where to buy Amphirion Plus

Contact Medtronic, Inc. directly; they can quote, ship, or point you to the distributor for your country.

From medtronic.com, checked October 2026.

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Amphirion Plus models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
AHU020014102Outer Diameter 2.0 mm; Length 14.0 mm Not statedAvailable
AHU020014152Length 14.0 mm; Outer Diameter 2.0 mm Not statedAvailable
AHU020030102Length 30.0 mm; Outer Diameter 2.0 mm Not statedAvailable
AHU020030152Outer Diameter 2.0 mm; Length 30.0 mm Not statedAvailable
AHU020060102Outer Diameter 2.0 mm; Length 60.0 mm Not statedAvailable
AHU020060152Length 60.0 mm; Outer Diameter 2.0 mm Not statedAvailable
AHU020080102Outer Diameter 2.0 mm; Length 80.0 mm Not statedAvailable
AHU020080152Length 80.0 mm; Outer Diameter 2.0 mm Not statedAvailable
AHU020120102Outer Diameter 2.0 mm; Length 120.0 mm Not statedAvailable
AHU020120152Length 120.0 mm; Outer Diameter 2.0 mm Not statedAvailable
AHU025014102Outer Diameter 2.5 mm; Length 14.0 mm Not statedAvailable
AHU025014152Outer Diameter 2.5 mm; Length 14.0 mm Not statedAvailable
AHU025030102Outer Diameter 2.5 mm; Length 30.0 mm Not statedAvailable
AHU025030152Length 30.0 mm; Outer Diameter 2.5 mm Not statedAvailable
AHU025060102Outer Diameter 2.5 mm; Length 60.0 mm Not statedAvailable
AHU025060152Outer Diameter 2.5 mm; Length 60.0 mm Not statedAvailable
AHU025080102Outer Diameter 2.5 mm; Length 80.0 mm Not statedAvailable
AHU025080152Length 80.0 mm; Outer Diameter 2.5 mm Not statedAvailable
AHU025120102Outer Diameter 2.5 mm; Length 120.0 mm Not statedAvailable
AHU025120152Length 120.0 mm; Outer Diameter 2.5 mm Not statedAvailable
AHU030014102Length 14.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030014152Length 14.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030030102Length 30.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030030152Length 30.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030060102Length 60.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030060152Outer Diameter 3.0 mm; Length 60.0 mm Not statedAvailable
AHU030080102Length 80.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030080152Length 80.0 mm; Outer Diameter 3.0 mm Not statedAvailable
AHU030120102Outer Diameter 3.0 mm; Length 120.0 mm Not statedAvailable
AHU030120152Outer Diameter 3.0 mm; Length 120.0 mm Not statedAvailable
AHU035014102Outer Diameter 3.5 mm; Length 14.0 mm Not statedAvailable
AHU035014152Outer Diameter 3.5 mm; Length 14.0 mm Not statedAvailable
AHU035030102Outer Diameter 3.5 mm; Length 30.0 mm Not statedAvailable
AHU035030152Length 30.0 mm; Outer Diameter 3.5 mm Not statedAvailable
AHU035060102Length 60.0 mm; Outer Diameter 3.5 mm Not statedAvailable
AHU035060152Outer Diameter 3.5 mm; Length 60.0 mm Not statedAvailable
AHU035080102Length 80.0 mm; Outer Diameter 3.5 mm Not statedAvailable
AHU035080152Outer Diameter 3.5 mm; Length 80.0 mm Not statedAvailable
AHU035120102Outer Diameter 3.5 mm; Length 120.0 mm Not statedAvailable
AHU035120152Length 120.0 mm; Outer Diameter 3.5 mm Not statedAvailable
AHU040014102Outer Diameter 4.0 mm; Length 14.0 mm Not statedAvailable
AHU040014152Length 14.0 mm; Outer Diameter 4.0 mm Not statedAvailable
AHU040030102Outer Diameter 4.0 mm; Length 30.0 mm Not statedAvailable
AHU040030152Length 30.0 mm; Outer Diameter 4.0 mm Not statedAvailable

FDA clearances

  • 510(k) K121265 May 2012

Procedures that use angioplasty balloons

Frequently asked questions

What is Amphirion Plus used for?

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Who makes Amphirion Plus?

Amphirion Plus is made by Medtronic, Inc.. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Amphirion Plus come in?

Sizes listed for Amphirion Plus: Length: 14–120 mm; Outer Diameter: 2–4 mm. Confirm availability with the manufacturer's instructions for use.

Is Amphirion Plus MRI safe?

The FDA device database entry for Amphirion Plus does not state its MRI safety status. Check the labeling before MRI.

Is Amphirion Plus FDA cleared?

Amphirion Plus is covered by FDA submission K121265.

How do I contact a Medtronic, Inc. sales representative?

Medtronic, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic, Inc. company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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