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glider pta balloon catheter
Trireme Medical
Summary: The Glider PTA Balloon Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat stenotic or obstructed blood vessels.
FDA Clearance Information
Pathway
510K
Number
K094019 ↗
Decision Date
February 12, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Glider PTA Balloon Catheter by Trireme Medical was cleared through the FDA 510(k) pathway on February 12, 2010. It is classified as a Class 2 device under product code DQY.
What It Is
The Glider PTA Balloon Catheter is a specialized catheter designed for percutaneous transluminal angioplasty. It features a balloon at its tip that can be inflated to dilate narrowed or obstructed blood vessels, improving blood flow. This device is particularly useful in treating peripheral vascular disease and is designed to navigate tortuous vascular anatomy with precision.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Glider PTA Balloon Catheter is employed in procedures to treat peripheral artery disease. It is suitable for use in both hospital and outpatient settings, and is often used in patients with atherosclerotic disease affecting the lower extremities. The device is essential in restoring patency to occluded vessels and improving circulation.
Indications for Use
The FDA-cleared indications for the Glider PTA Balloon Catheter include use in patients with stenotic or obstructed peripheral arteries. It is intended for use in procedures aimed at dilating these vessels to improve blood flow.
Practical Considerations
The Glider PTA Balloon Catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths, and its design allows for precise navigation through complex vascular pathways.
Frequently Asked Questions
What is the Glider PTA Balloon Catheter used for?
It is used for dilating narrowed or obstructed blood vessels in peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for use in dilating stenotic or obstructed peripheral arteries to improve blood flow.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.