Angioplasty balloons
Polux PTA Balloon Dilatation Catheterrev 01
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 Polux PTA Balloon Dilatation Catheterrev 01
Contact BrosMed Medical Co.,Ltd. directly; they can quote, ship, or point you to the distributor for your country.
From brosmed.com, checked October 2026.
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Polux PTA Balloon Dilatation Catheterrev 01 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 |
|---|---|---|---|
| rev 01 | — | Not stated | Available |
FDA clearances
- 510(k) K160256 July 2016
Procedures that use angioplasty balloons
Frequently asked questions
What is Polux PTA Balloon Dilatation Catheterrev 01 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 Polux PTA Balloon Dilatation Catheterrev 01?
Polux PTA Balloon Dilatation Catheterrev 01 is made by BrosMed Medical Co.,Ltd.. It is listed under peripheral angioplasty balloons in our device library.
What sizes does Polux PTA Balloon Dilatation Catheterrev 01 come in?
The FDA device database does not list sizes for Polux PTA Balloon Dilatation Catheterrev 01. Check the instructions for use or ask a BrosMed Medical Co.,Ltd. representative.
Is Polux PTA Balloon Dilatation Catheterrev 01 MRI safe?
The FDA device database entry for Polux PTA Balloon Dilatation Catheterrev 01 does not state its MRI safety status. Check the labeling before MRI.
Is Polux PTA Balloon Dilatation Catheterrev 01 FDA cleared?
Polux PTA Balloon Dilatation Catheterrev 01 is covered by FDA submission K160256.
How do I contact a BrosMed Medical Co.,Ltd. sales representative?
BrosMed Medical Co.,Ltd. has not listed representatives on LA Vascular yet. Visit the BrosMed Medical Co.,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.