Angioplasty balloons

Gliderflex PTA Balloon Catheter

by Trireme Medical, LLC

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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Gliderflex PTA Balloon Catheter models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

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FDA clearances

  • 510(k) K101062 May 2010

Procedures that use angioplasty balloons

Frequently asked questions

What is Gliderflex PTA Balloon 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 Gliderflex PTA Balloon Catheter?

Gliderflex PTA Balloon Catheter is made by Trireme Medical, LLC. It is listed under peripheral angioplasty balloons in our device library.

What sizes does Gliderflex PTA Balloon Catheter come in?

The FDA device database does not list sizes for Gliderflex PTA Balloon Catheter. Check the instructions for use or ask a Trireme Medical, LLC representative.

Is Gliderflex PTA Balloon Catheter MRI safe?

The FDA device database entry for Gliderflex PTA Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.

Is Gliderflex PTA Balloon Catheter FDA cleared?

Gliderflex PTA Balloon Catheter is covered by FDA submission K101062.

How do I contact a Trireme Medical, LLC sales representative?

Trireme Medical, LLC has not listed representatives on LA Vascular yet. Visit the Trireme Medical, LLC 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.

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