Angioplasty balloons
Biotronik Passeo-35 HP
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 Biotronik Passeo-35 HP
We do not have contact details for Creagh Medical Limited yet. Send a request and we will route it to the right person for your country.
Biotronik Passeo-35 HP 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 |
|---|---|---|---|
| 3/40/75 | Length 40 mm; Outer Diameter 3.0 mm | Not stated | Available |
| 4/20/75 | Length 20 mm; Outer Diameter 4.0 mm | Not stated | Available |
| 4/40/75 | Length 40 mm; Outer Diameter 4.0 mm | Not stated | Available |
| 5/20/75 | Length 20 mm; Outer Diameter 5.0 mm | Not stated | Available |
| 5/40/75 | Length 40 mm; Outer Diameter 5.0 mm | Not stated | Available |
| 5/60/75 | Length 60 mm; Outer Diameter 5.0 mm | Not stated | Available |
| 6/20/75 | Length 20 mm; Outer Diameter 6.0 mm | Not stated | Available |
| 6/40/40 | Length 40 mm; Outer Diameter 6.0 mm | Not stated | Available |
| 6/40/75 | Length 40 mm; Outer Diameter 6.0 mm | Not stated | Available |
| 6/60/75 | Length 60 mm; Outer Diameter 6.0 mm | Not stated | Available |
| 6/100/75 | Length 100 mm; Outer Diameter 6.0 mm | Not stated | Available |
| 7/20/75 | Length 20 mm; Outer Diameter 7.0 mm | Not stated | Available |
| 7/40/40 | Length 40 mm; Outer Diameter 7.0 mm | Not stated | Available |
| 7/40/75 | Length 40 mm; Outer Diameter 7.0 mm | Not stated | Available |
| 7/60/75 | Length 60 mm; Outer Diameter 7.0 mm | Not stated | Available |
| 7/100/75 | Length 100 mm; Outer Diameter 7.0 mm | Not stated | Available |
| 8/20/75 | Length 20 mm; Outer Diameter 8.0 mm | Not stated | Available |
| 8/40/40 | Length 40 mm; Outer Diameter 8.0 mm | Not stated | Available |
| 8/40/75 | Length 40 mm; Outer Diameter 8.0 mm | Not stated | Available |
| 8/60/75 | Length 60 mm; Outer Diameter 8.0 mm | Not stated | Available |
| 8/80/75 | Length 80 mm; Outer Diameter 8.0 mm | Not stated | Available |
| 9/40/75 | Length 40 mm; Outer Diameter 9.0 mm | Not stated | Available |
| 10/40/75 | Length 40 mm; Outer Diameter 10.0 mm | Not stated | Available |
| 12/40/75 | Length 40 mm; Outer Diameter 12.0 mm | Not stated | Available |
FDA clearances
- 510(k) K113468 December 2011
Procedures that use angioplasty balloons
Frequently asked questions
What is Biotronik Passeo-35 HP 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 Biotronik Passeo-35 HP?
Biotronik Passeo-35 HP is made by Creagh Medical Limited. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Biotronik Passeo-35 HP come in?
Sizes listed for Biotronik Passeo-35 HP: Length: 20–100 mm; Outer Diameter: 3–12 mm. Confirm availability with the manufacturer's instructions for use.
Is Biotronik Passeo-35 HP MRI safe?
The FDA device database entry for Biotronik Passeo-35 HP does not state its MRI safety status. Check the labeling before MRI.
Is Biotronik Passeo-35 HP FDA cleared?
Biotronik Passeo-35 HP is covered by FDA submission K113468.
How do I contact a Creagh Medical Limited sales representative?
Creagh Medical Limited has not listed representatives on LA Vascular yet. Visit the Creagh Medical Limited 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.