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angiodynamics profiler pta balloon catheter
Angiodynamics
Summary: The Angiodynamics Profiler PTA Balloon Catheter is a medical device used to dilate narrowed blood vessels, commonly employed by interventional radiologists and vascular surgeons. It is primarily used in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K051060 ↗
Decision Date
May 26, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Angiodynamics Profiler PTA Balloon Catheter was cleared through the FDA 510(k) pathway on May 26, 2005. Manufactured by Angiodynamics, it is classified as a Class 2 device under product code DQY.
What It Is
The Angiodynamics Profiler PTA Balloon Catheter is a percutaneous transluminal angioplasty (PTA) device designed to dilate stenotic segments of blood vessels. It consists of a balloon at the tip of a catheter, which is inflated to open up narrowed areas in the vasculature. This device is crucial in restoring adequate blood flow and is often used in conjunction with stenting procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients with peripheral artery disease or venous obstructions. It is typically utilized in hospital catheterization labs or outpatient vascular centers. The patient population includes those with atherosclerosis or other conditions leading to vascular stenosis.
Indications for Use
The FDA-cleared indications for this device involve its use in dilating narrowed blood vessels, particularly in the venous system. It is suitable for patients with conditions that cause vessel narrowing, such as peripheral artery disease.
Practical Considerations
The Angiodynamics Profiler PTA Balloon Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful technique to ensure precise placement and inflation. Clinicians should be aware of the potential for vessel injury and ensure proper sizing to minimize complications.
Frequently Asked Questions
What is the Angiodynamics Profiler PTA Balloon Catheter used for?
It is used to dilate narrowed blood vessels, particularly in the venous system, to restore adequate blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for dilating narrowed blood vessels, especially in the venous system, to treat conditions like 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.