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chocolate pta balloon catheter over the wire guide wire 0 014 and 0 018
Trireme Medical
Summary: The Chocolate PTA Balloon Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat vascular stenosis. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K111738 ↗
Decision Date
December 14, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Chocolate PTA Balloon Catheter received FDA clearance through the 510(k) pathway on December 14, 2011. Manufactured by Trireme Medical, it is classified as a Class 2 medical device.
What It Is
The Chocolate PTA Balloon Catheter is designed for use in percutaneous transluminal angioplasty (PTA) procedures. It features a unique constraining structure that helps maintain the balloon's shape, reducing vessel trauma and improving procedural outcomes. This device is used to dilate narrowed or obstructed blood vessels, typically in the peripheral vasculature.
Clinical Applications
This device is commonly used in procedures to treat peripheral artery disease (PAD), particularly in the lower extremities. It is often employed in interventional radiology and vascular surgery settings. Patients with atherosclerotic disease causing stenosis or occlusion in peripheral arteries are typical candidates for this intervention.
Indications for Use
The FDA indications for the Chocolate PTA Balloon Catheter include its use in dilating stenotic segments of peripheral arteries. It is particularly indicated for patients with peripheral artery disease who require revascularization to improve blood flow.
Practical Considerations
The Chocolate PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters and lengths. It is compatible with 0.014 and 0.018 inch guide wires, which are commonly used in peripheral interventions. Clinicians should be familiar with the device's unique structure to optimize procedural technique.
Frequently Asked Questions
What is the Chocolate PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or obstructed peripheral arteries.
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 dilating stenotic segments of peripheral arteries in patients with peripheral artery disease.
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.