Angioplasty balloons
Fortrex
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 Medtronic, Inc. 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.
Fortrex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| A35HPV04020040 | Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV04020080 | Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm; Length 80.0 cm | Not stated | Available |
| A35HPV04020135 | Catheter Gauge 6.0 Fr; Length 135.0 cm; Outer Diameter 4.0 mm | Not stated | Available |
| A35HPV04040040 | Catheter Gauge 6.0 Fr; Length 40.0 cm; Outer Diameter 4.0 mm | Not stated | Available |
| A35HPV04040080 | Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm | Not stated | Available |
| A35HPV04040135 | Length 135.0 cm; Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV04080040 | Catheter Gauge 6.0 Fr; Length 40.0 cm; Outer Diameter 4.0 mm | Not stated | Available |
| A35HPV04080080 | Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm | Not stated | Available |
| A35HPV04080135 | Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm; Length 135.0 cm | Not stated | Available |
| A35HPV04100040 | Catheter Gauge 6.0 Fr; Outer Diameter 4.0 mm; Length 40.0 cm | Not stated | Available |
| A35HPV04100080 | Length 80.0 cm; Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV04100135 | Length 135.0 cm; Outer Diameter 4.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV05020040 | Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm; Length 40.0 cm | Not stated | Available |
| A35HPV05020080 | Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm | Not stated | Available |
| A35HPV05020135 | Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm | Not stated | Available |
| A35HPV05040040 | Length 40.0 cm; Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV05040080 | Length 80.0 cm; Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV05040135 | Catheter Gauge 6.0 Fr; Length 135.0 cm; Outer Diameter 5.0 mm | Not stated | Available |
| A35HPV05080040 | Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV05080080 | Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 5.0 mm | Not stated | Available |
| A35HPV05080135 | Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm | Not stated | Available |
| A35HPV05100040 | Length 40.0 cm; Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV05100080 | Catheter Gauge 6.0 Fr; Length 80.0 cm; Outer Diameter 5.0 mm | Not stated | Available |
| A35HPV05100135 | Length 135.0 cm; Outer Diameter 5.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV06020040 | Length 40.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm | Not stated | Available |
| A35HPV06020080 | Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm; Length 80.0 cm | Not stated | Available |
| A35HPV06020135 | Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm | Not stated | Available |
| A35HPV06040040 | Outer Diameter 6.0 mm; Length 40.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV06040080 | Outer Diameter 6.0 mm; Length 80.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV06040135 | Length 135.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm | Not stated | Available |
| A35HPV06080040 | Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV06080080 | Outer Diameter 6.0 mm; Length 80.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV06080135 | Length 135.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm | Not stated | Available |
| A35HPV06100040 | Length 40.0 cm; Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV06100080 | Catheter Gauge 6.0 Fr; Outer Diameter 6.0 mm; Length 80.0 cm | Not stated | Available |
| A35HPV06100135 | Outer Diameter 6.0 mm; Catheter Gauge 6.0 Fr; Length 135.0 cm | Not stated | Available |
| A35HPV07020040 | Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV07020080 | Length 80.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV07020080 | Catheter Gauge 6.0 Fr; Length 80.0 cm; Outer Diameter 7.0 mm | Not stated | Available |
| A35HPV07020135 | Length 135.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV07040040 | Outer Diameter 7.0 mm; Length 40.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV07040080 | Length 80.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 7.0 mm | Not stated | Available |
| A35HPV07040135 | Length 135.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV07080040 | Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV07080080 | Catheter Gauge 6.0 Fr; Length 80.0 cm; Outer Diameter 7.0 mm | Not stated | Available |
| A35HPV07080135 | Outer Diameter 7.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV07100040 | Catheter Gauge 6.0 Fr; Outer Diameter 7.0 mm; Length 40.0 cm | Not stated | Available |
| A35HPV07100080 | Outer Diameter 7.0 mm; Length 80.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV07100135 | Length 135.0 cm; Outer Diameter 7.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV08040040 | Length 40.0 cm; Catheter Gauge 6.0 Fr; Outer Diameter 8.0 mm | Not stated | Available |
| A35HPV08040080 | Outer Diameter 8.0 mm; Catheter Gauge 6.0 Fr; Length 80.0 cm | Not stated | Available |
| A35HPV08040135 | Catheter Gauge 6.0 Fr; Length 135.0 cm; Outer Diameter 8.0 mm | Not stated | Available |
| A35HPV08080040 | Outer Diameter 8.0 mm; Catheter Gauge 6.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV08080080 | Catheter Gauge 6.0 Fr; Outer Diameter 8.0 mm; Length 80.0 cm | Not stated | Available |
| A35HPV08080135 | Length 135.0 cm; Outer Diameter 8.0 mm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV08100040 | Catheter Gauge 6.0 Fr; Length 40.0 cm; Outer Diameter 8.0 mm | Not stated | Available |
| A35HPV08100080 | Catheter Gauge 6.0 Fr; Outer Diameter 8.0 mm; Length 80.0 cm | Not stated | Available |
| A35HPV08100135 | Outer Diameter 8.0 mm; Length 135.0 cm; Catheter Gauge 6.0 Fr | Not stated | Available |
| A35HPV09040040 | Length 40.0 cm; Outer Diameter 9.0 mm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV09040080 | Outer Diameter 9.0 mm; Catheter Gauge 7.0 Fr; Length 80.0 cm | Not stated | Available |
| A35HPV09040135 | Length 135.0 cm; Outer Diameter 9.0 mm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV09080040 | Outer Diameter 9.0 mm; Length 40.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV09080080 | Length 80.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 9.0 mm | Not stated | Available |
| A35HPV09080135 | Outer Diameter 9.0 mm; Length 135.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV10040040 | Outer Diameter 10.0 mm; Length 40.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV10040080 | Outer Diameter 10.0 mm; Catheter Gauge 7.0 Fr; Length 80.0 cm | Not stated | Available |
| A35HPV10040135 | Outer Diameter 10.0 mm; Length 135.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV10080040 | Outer Diameter 10.0 mm; Length 40.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV10080080 | Catheter Gauge 7.0 Fr; Outer Diameter 10.0 mm; Length 80.0 cm | Not stated | Available |
| A35HPV10080135 | Outer Diameter 10.0 mm; Length 135.0 cm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV12040040 | Outer Diameter 12.0 mm; Catheter Gauge 7.0 Fr; Length 40.0 cm | Not stated | Available |
| A35HPV12040080 | Length 80.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 12.0 mm | Not stated | Available |
| A35HPV12040135 | Length 135.0 cm; Outer Diameter 12.0 mm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV12080040 | Length 40.0 cm; Outer Diameter 12.0 mm; Catheter Gauge 7.0 Fr | Not stated | Available |
| A35HPV12080080 | Length 80.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 12.0 mm | Not stated | Available |
| A35HPV12080135 | Length 135.0 cm; Catheter Gauge 7.0 Fr; Outer Diameter 12.0 mm | Not stated | Available |
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 Medtronic, Inc.. 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; Catheter Gauge: 6–7 Fr; Length: 40–135 cm. 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 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.