Angioplasty balloons

Fortrex

by Covidien LP

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 Fortrex

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

From medtronic.com, checked October 2026.

No reply, or outside their markets? Send us a request and we route it to a rep or distributor for your country.

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Fortrex models and sizes

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

Model / catalog no.SizeMRIStatus
A35HPV04020040Outer Diameter 4 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04020040Outer Diameter 4.0 mm; Length 40.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV04020080Length 80.0 cm; Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV04020080Outer Diameter 4 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04020135Length 135.0 cm; Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV04020135Length 135 cm; Outer Diameter 4 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04040040Outer Diameter 4.0 mm; Length 40.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV04040040Outer Diameter 4 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04040080Outer Diameter 4 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04040080Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm; Length 80.0 cm Not statedAvailable
A35HPV04040135Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm; Length 135.0 cm Not statedAvailable
A35HPV04040135Outer Diameter 4 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04080040Catheter Gauge 6 Fr; Length 40 cm; Outer Diameter 4 mm Not statedAvailable
A35HPV04080040Catheter Gauge 6.0 Fr; Length 40.0 cm; Outer Diameter 4.0 mm Not statedAvailable
A35HPV04080080Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm Not statedAvailable
A35HPV04080080Outer Diameter 4 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04080135Outer Diameter 4.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV04080135Length 135 cm; Outer Diameter 4 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04100040Outer Diameter 4 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04100040Length 40.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm Not statedAvailable
A35HPV04100080Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm Not statedAvailable
A35HPV04100080Length 80 cm; Outer Diameter 4 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04100135Outer Diameter 4 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV04100135Length 135.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm Not statedAvailable
A35HPV05020040Catheter Gauge 6.0 Fr; Length 40.0 cm; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05020040Outer Diameter 5 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV05020080Outer Diameter 5 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV05020080Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05020135Outer Diameter 5.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV05020135Catheter Gauge 6.0 Fr; Length 135.0 cm; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05040040Length 40 cm; Outer Diameter 5 mm Not statedAvailable
A35HPV05040040Length 40.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05040080Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm Not statedAvailable
A35HPV05040080Outer Diameter 6 mm Not statedAvailable
A35HPV05040135Length 135.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05040135Outer Diameter 5 mm; Length 135 cm Not statedAvailable
A35HPV05080040Catheter Gauge 6 Fr Not statedAvailable
A35HPV05080040Length 40.0 cm; Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV05080080Length 80 cm; Outer Diameter 5 mm Not statedAvailable
A35HPV05080080Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05080135Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV05080135Outer Diameter 5 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV05100040Outer Diameter 5 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV05100040Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm Not statedAvailable
A35HPV05100080Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm Not statedAvailable
A35HPV05100080Outer Diameter 5 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV05100135Catheter Gauge 6 Fr; Outer Diameter 5 mm; Length 135 cm Not statedAvailable
A35HPV05100135Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV06020040Length 40 cm; Outer Diameter 6 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06020040Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm; Length 40.0 cm Not statedAvailable
A35HPV06020080Catheter Gauge 6.0 Fr; Length 80.0 cm; Outer Diameter 6.0 mm Not statedAvailable
A35HPV06020080Catheter Gauge 6 Fr; Length 80 cm; Outer Diameter 6 mm Not statedAvailable
A35HPV06020135Length 135 cm; Outer Diameter 6 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06020135Length 135.0 cm; Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV06040040Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm Not statedAvailable
A35HPV06040040Outer Diameter 6 mm; Length 40 cm Not statedAvailable
A35HPV06040080Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm Not statedAvailable
A35HPV06040080Outer Diameter 6 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06040135Catheter Gauge 6.0 Fr; Length 135.0 cm; Outer Diameter 6.0 mm Not statedAvailable
A35HPV06040135Catheter Gauge 6 Fr; Length 135 cm; Outer Diameter 6 mm Not statedAvailable
A35HPV06080040Outer Diameter 6 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06080040Length 40.0 cm; Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV06080080Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm Not statedAvailable
A35HPV06080080Length 80 cm; Outer Diameter 6 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06080135Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV06080135Length 135 cm; Outer Diameter 6 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06100040Length 40.0 cm; Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV06100040Length 40 cm; Outer Diameter 6 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV06100080Outer Diameter 6 mm; Length 80 cm Not statedAvailable
A35HPV06100080Length 80.0 cm; Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV06100135Outer Diameter 6.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV06100135Outer Diameter 6 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07020040Length 40.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV07020040Catheter Gauge 6 Fr Not statedAvailable
A35HPV07020080Outer Diameter 7 mm; Length 80 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07020135Outer Diameter 7 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07020135Outer Diameter 7.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV07040040Catheter Gauge 6.0 Fr; Length 40.0 cm; Outer Diameter 7.0 mm Not statedAvailable
A35HPV07040040Outer Diameter 7 mm; Length 40 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07040080Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm Not statedAvailable
A35HPV07040080Length 80 cm; Outer Diameter 7 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07040135Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV07040135Outer Diameter 7 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07080040Outer Diameter 7.0 mm; Length 40.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV07080040Length 40 cm; Outer Diameter 7 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07080080Length 80 cm; Outer Diameter 7 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07080080Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm Not statedAvailable
A35HPV07080135Length 135.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV07080135Outer Diameter 7 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07100040Length 40 cm; Outer Diameter 7 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV07100040Length 40.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV07100080Outer Diameter 7 mm; Length 80 cm Not statedAvailable
A35HPV07100080Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 7.0 mm Not statedAvailable
A35HPV07100135Outer Diameter 7.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV07100135Outer Diameter 7 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV08040040Length 40 cm; Outer Diameter 8 mm Not statedAvailable
A35HPV08040040Catheter Gauge 6.0 Fr; Outer Diameter 8.0 mm; Length 40.0 cm Not statedAvailable
A35HPV08040080Outer Diameter 8 mm; Length 80 cm Not statedAvailable
A35HPV08040080Outer Diameter 8.0 mm; Length 80.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV08040135Outer Diameter 8.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV08040135Outer Diameter 8 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV08080040Length 40 cm; Outer Diameter 8 mm Not statedAvailable
A35HPV08080040Catheter Gauge 6.0 Fr; Outer Diameter 8.0 mm; Length 40.0 cm Not statedAvailable
A35HPV08080080Length 80 cm; Outer Diameter 8 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV08080080Length 80.0 cm; Outer Diameter 8.0 mm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV08080135Outer Diameter 8 mm; Length 135 cm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV08080135Catheter Gauge 6.0 Fr; Length 135.0 cm; Outer Diameter 8.0 mm Not statedAvailable
A35HPV08100040Length 40 cm; Outer Diameter 8 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV08100040Outer Diameter 8.0 mm; Length 40.0 cm; Catheter Gauge 6.0 Fr Not statedAvailable
A35HPV08100080Catheter Gauge 6.0 Fr; Length 80.0 cm; Outer Diameter 8.0 mm Not statedAvailable
A35HPV08100080Catheter Gauge 6 Fr; Length 80 cm; Outer Diameter 8 mm Not statedAvailable
A35HPV08100135Length 135 cm; Outer Diameter 8 mm; Catheter Gauge 6 Fr Not statedAvailable
A35HPV08100135Outer Diameter 8.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV09040040Length 40 cm; Outer Diameter 9 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV09040040Catheter Gauge 7.0 Fr; Outer Diameter 9.0 mm; Length 40.0 cm Not statedAvailable
A35HPV09040080Length 80 cm; Outer Diameter 9 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV09040080Outer Diameter 9.0 mm; Length 80.0 cm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV09040135Outer Diameter 9.0 mm; Catheter Gauge 7.0 Fr; Length 135.0 cm Not statedAvailable
A35HPV09040135Outer Diameter 9 mm; Length 135 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV09080040Length 40 cm; Outer Diameter 9 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV09080040Outer Diameter 9.0 mm; Catheter Gauge 7.0 Fr; Length 40.0 cm Not statedAvailable
A35HPV09080080Outer Diameter 9.0 mm; Length 80.0 cm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV09080080Length 80 cm; Outer Diameter 9 mm Not statedAvailable
A35HPV09080135Catheter Gauge 7.0 Fr; Outer Diameter 9.0 mm; Length 135.0 cm Not statedAvailable
A35HPV09080135Outer Diameter 9 mm; Length 135 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10040040Catheter Gauge 7.0 Fr; Length 40.0 cm; Outer Diameter 10.0 mm Not statedAvailable
A35HPV10040040Length 40 cm; Outer Diameter 10 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10040080Length 80.0 cm; Outer Diameter 10.0 mm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV10040080Outer Diameter 10 mm; Length 80 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10040135Outer Diameter 10 mm; Length 135 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10040135Length 135.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 10.0 mm Not statedAvailable
A35HPV10080040Outer Diameter 10 mm; Length 40 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10080040Outer Diameter 10.0 mm; Catheter Gauge 7.0 Fr; Length 40.0 cm Not statedAvailable
A35HPV10080080Outer Diameter 10.0 mm; Catheter Gauge 7.0 Fr; Length 80.0 cm Not statedAvailable
A35HPV10080080Length 80 cm; Outer Diameter 10 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10080135Outer Diameter 10 mm; Length 135 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV10080135Catheter Gauge 7.0 Fr; Length 135.0 cm; Outer Diameter 10.0 mm Not statedAvailable
A35HPV12040040Outer Diameter 12 mm; Length 40 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV12040040Catheter Gauge 7.0 Fr; Length 40.0 cm; Outer Diameter 12.0 mm Not statedAvailable
A35HPV12040080Outer Diameter 12 mm; Length 80 cm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV12040080Length 80.0 cm; Outer Diameter 12.0 mm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV12040135Length 135.0 cm; Outer Diameter 12.0 mm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV12040135Length 135 cm; Outer Diameter 12 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV12080040Length 40 cm; Outer Diameter 12 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV12080040Catheter Gauge 7.0 Fr; Outer Diameter 12.0 mm; Length 40.0 cm Not statedAvailable
A35HPV12080080Length 80 cm; Outer Diameter 12 mm; Catheter Gauge 7 Fr Not statedAvailable
A35HPV12080080Outer Diameter 12.0 mm; Length 80.0 cm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV12080135Outer Diameter 12.0 mm; Length 135.0 cm; Catheter Gauge 7.0 Fr Not statedAvailable
A35HPV12080135Outer Diameter 12 mm; Length 135 cm; Catheter Gauge 7 Fr Not statedAvailable

FDA clearances

  • 510(k) K142654 October 2014

Procedures that use angioplasty balloons

Frequently asked questions

What is Fortrex 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 Fortrex?

Fortrex is made by Covidien LP. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Fortrex come in?

Sizes listed for Fortrex: Outer Diameter: 4–12 mm; Length: 40–135 cm; Catheter Gauge: 6–7 Fr. Confirm availability with the manufacturer's instructions for use.

Is Fortrex MRI safe?

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

Is Fortrex FDA cleared?

Fortrex is covered by FDA submission K142654.

How do I contact a Covidien LP sales representative?

Covidien LP has not listed representatives on LA Vascular yet. Visit the Covidien LP 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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