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modification to angiodynamics profiler pta balloon catheter
Angiodynamics
Summary: The Angiodynamics Profiler PTA Balloon Catheter is a medical device used to dilate narrowed blood vessels, commonly in peripheral vascular interventions. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K062609 ↗
Decision Date
October 6, 2006
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 October 6, 2006. 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 that is inflated at the site of narrowing to restore vessel patency. This device is essential in procedures aiming to improve blood flow in peripheral arteries, particularly in patients with peripheral artery disease (PAD).
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings to treat peripheral artery disease. It is particularly useful in procedures involving the dilation of stenotic lesions in the iliac, femoral, and popliteal arteries. The catheter is suitable for use in both inpatient and outpatient settings, and it is often employed in patients who present with symptoms of claudication or critical limb ischemia.
Indications for Use
The FDA-cleared indications for the Angiodynamics Profiler PTA Balloon Catheter include the treatment of narrowed blood vessels in the peripheral vascular system. It is intended for patients with conditions such as peripheral artery disease, where blood flow is restricted due to vessel narrowing.
Practical Considerations
The Angiodynamics Profiler PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should ensure proper balloon sizing relative to the target vessel to optimize procedural outcomes and minimize complications.
Frequently Asked Questions
What is the Angiodynamics Profiler PTA Balloon Catheter used for?
It is used to dilate narrowed peripheral arteries to restore blood flow in patients with peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in peripheral vascular interventions.
What are the FDA-cleared indications?
The device is indicated for the dilation of stenotic segments in peripheral arteries, particularly 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.