Angioplasty balloons
Polux 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.
Find similar PTA balloons
Where to buy Polux PTA Balloon Dilatation Catheter
We do not have contact details for BrosMed Medical Co.,Ltd. yet. Send a request and we will route it to the right person for your country.
Polux 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 |
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| rev 01 | — | Not stated | Available |
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FDA clearances
- 510(k) K160256 July 2016
Procedures that use angioplasty balloons
Frequently asked questions
What is Polux 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 Polux PTA Balloon Dilatation Catheter?
Polux PTA Balloon Dilatation Catheter 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 Catheter come in?
The FDA device database does not list sizes for Polux PTA Balloon Dilatation Catheter. Check the instructions for use or ask a BrosMed Medical Co.,Ltd. representative.
Is Polux PTA Balloon Dilatation Catheter MRI safe?
The FDA device database entry for Polux PTA Balloon Dilatation Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Polux PTA Balloon Dilatation Catheter FDA cleared?
Polux PTA Balloon Dilatation Catheter 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.