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gliderxtreme pta balloon catheter cb over the wire 0 014 0 018 guide wire
Trireme Medical
Summary: The GliderXtreme PTA Balloon Catheter is a medical device used primarily by interventional radiologists and vascular surgeons for percutaneous transluminal angioplasty (PTA) procedures. It is designed to treat vascular stenosis in venous stents.
FDA Clearance Information
Pathway
510K
Number
K103534 ↗
Decision Date
January 5, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The GliderXtreme PTA Balloon Catheter by Trireme Medical was cleared through the FDA 510(k) pathway on January 5, 2011. It is a Class II device under product code DQY.
What It Is
The GliderXtreme PTA Balloon Catheter is a specialized catheter used in minimally invasive procedures to dilate narrowed or obstructed blood vessels. It operates over a guidewire, typically 0.014 or 0.018 inches in diameter, allowing precise navigation and placement. The balloon can be inflated to widen the vessel, improving blood flow and relieving symptoms associated with vascular stenosis.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients with venous stenosis. It is suitable for use in hospitals and outpatient surgical centers. The catheter is often employed in procedures involving venous stents, where it helps maintain patency and prevent restenosis, benefiting patients with conditions like deep vein thrombosis or post-thrombotic syndrome.
Indications for Use
The FDA-cleared indications for the GliderXtreme PTA Balloon Catheter include the treatment of narrowed blood vessels within venous stents. It is intended for patients experiencing reduced blood flow due to stenosis, which can lead to complications if left untreated.
Practical Considerations
The GliderXtreme PTA Balloon Catheter is compatible with 0.014 and 0.018 inch guidewires, offering flexibility in various procedural contexts. Clinicians should ensure proper sizing of the balloon relative to the vessel diameter to optimize outcomes and minimize complications. Familiarity with angioplasty techniques is essential for effective use.
Frequently Asked Questions
What is the GliderXtreme PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to treat vascular stenosis, particularly within venous stents.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for treating narrowed blood vessels within venous stents 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.