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atb advance pta dilatation catheter
Cook
Summary: The ATB Advance PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K052036 ↗
Decision Date
August 25, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ATB Advance PTA Dilatation Catheter was cleared through the FDA 510(k) pathway on August 25, 2005. Manufactured by Cook, it is classified as a Class II device under product code DQY.
What It Is
The ATB Advance PTA Dilatation Catheter is designed for use in percutaneous transluminal angioplasty procedures. It works by inflating a balloon at the site of a vascular stenosis to widen the vessel and improve blood flow. The catheter is typically inserted through a small incision and guided to the target site using imaging techniques.
Clinical Applications
This device is commonly used in procedures to treat peripheral artery disease, particularly in the lower extremities. It is often utilized in hospital settings, outpatient surgical centers, and specialized vascular clinics. The primary patient population includes those with atherosclerotic disease causing vessel narrowing.
Indications for Use
The FDA indications for this device include its use in dilating stenosed or obstructed peripheral arteries. It is suitable for patients with conditions that cause narrowing of blood vessels, such as peripheral artery disease.
Practical Considerations
The ATB Advance PTA Dilatation Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with angiographic techniques to ensure precise placement and inflation of the balloon.
Frequently Asked Questions
What is the ATB Advance PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed blood vessels, improving blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for dilating stenosed or obstructed 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.