Angioplasty balloons
All'InCath 035M PTA Balloon Dilatation Catheter
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 All'InCath 035M PTA Balloon Dilatation Catheter
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All'InCath 035M PTA Balloon Dilatation Catheter 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 |
|---|---|---|---|
| 1 | Catheter Working Length 80 cm; Balloon Diameter 7 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 8 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 mm; Balloon Diameter 7 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 4 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 8 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 6 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 8 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 8 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 4 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 7 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 6 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 4 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 5 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 6 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 mm; Balloon Diameter 10 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 6 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 4 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 9 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 8 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 10 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 8 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 6 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 7 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 5 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 8 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 mm; Balloon Diameter 10 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 5 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 7 mm; Balloon Length 40 cm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 9 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 6 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 6 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 9 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 5 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 7 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 7 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 5 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 10 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 5 mm; Balloon Length 60 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 mm; Balloon Diameter 7 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 11 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 4 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 4 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 9 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 14 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 4 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 4 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 18 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 12 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 5 mm; Balloon Length 40 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 120 cm; Balloon Diameter 6 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 10 Atmosphere | Not stated | Available |
| 1 | Catheter Length 80 cm; Balloon Diameter 5 mm; Balloon Length 80 mm; Balloon Rated Burst Pressure 16 Atmosphere; Introducer Sheath Compatibility 6 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 9 Atmosphere | Not stated | Available |
| 1 | Catheter Working Length 80 cm; Balloon Diameter 8 mm; Balloon Length 20 mm; Balloon Rated Burst Pressure 15 Atmosphere; Introducer Sheath Compatibility 7 Fr; Guidewire Compatibility 0.035 Fr; Pressure 1100 Pound per Square Inch; Balloon Nominal (Inflation) Pressure 8 Atmosphere | Not stated | Available |
FDA clearances
- 510(k) K191275 January 2020
Procedures that use angioplasty balloons
Frequently asked questions
What is All'InCath 035M PTA Balloon Dilatation Catheter 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 All'InCath 035M PTA Balloon Dilatation Catheter?
All'InCath 035M PTA Balloon Dilatation Catheter is made by Nexstep Medical. It is listed under peripheral angioplasty balloons in our device library.
What sizes does All'InCath 035M PTA Balloon Dilatation Catheter come in?
Sizes listed for All'InCath 035M PTA Balloon Dilatation Catheter: Balloon Diameter: 4–10 mm; Balloon Rated Burst Pressure: 14–18 Atmosphere; Introducer Sheath Compatibility: 6–7 Fr. Confirm availability with the manufacturer's instructions for use.
Is All'InCath 035M PTA Balloon Dilatation Catheter MRI safe?
The FDA device database entry for All'InCath 035M PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is All'InCath 035M PTA Balloon Dilatation Catheter FDA cleared?
All'InCath 035M PTA Balloon Dilatation Catheter is covered by FDA submission K191275.
How do I contact a Nexstep Medical sales representative?
Nexstep Medical has not listed representatives on LA Vascular yet. Visit the Nexstep Medical 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.