Angioplasty balloons
Proteus
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.
Proteus 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 |
|---|---|---|---|
| 1U-0420-135-03 | — | Not stated | Available |
| 1U-0440-135-02 | — | Not stated | Available |
| 1U-0460-135-02 | — | Not stated | Available |
| 1U-0480-135-02 | — | Not stated | Available |
| 1U-0520-135-02 | — | Not stated | Available |
| 1U-0540-135-04 | — | Not stated | Available |
| 1U-0560-135-03 | — | Not stated | Available |
| 1U-0620-135-02 | — | Not stated | Available |
| 1U-0640-135-02 | — | Not stated | Available |
| 1U-0660-135-03 | — | Not stated | Available |
| 1U-3100-135-02 | — | Not stated | Available |
| 1U-4100-135-02 | — | Not stated | Available |
| 1U-5100-135-03 | — | Not stated | Available |
| 1U-6100-135-03 | — | Not stated | Available |
FDA clearances
- 510(k) K172494 December 2017
- 510(k) K133043 December 2013
Procedures that use angioplasty balloons
Frequently asked questions
What is Proteus 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 Proteus?
Proteus is made by Angioslide Ltd. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Proteus come in?
The FDA device database does not list sizes for Proteus. Check the instructions for use or ask a Angioslide Ltd representative.
Is Proteus MRI safe?
The FDA device database entry for Proteus does not state its MRI safety status. Check the labeling before MRI.
Is Proteus FDA cleared?
Proteus is covered by FDA submissions K133043, K172494.
How do I contact a Angioslide Ltd sales representative?
Angioslide Ltd has not listed representatives on LA Vascular yet. Visit the Angioslide Ltd 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.