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atb all-terrain balloon pta dilatation catheter
Cook
Summary: The ATB All-Terrain Balloon PTA Dilatation Catheter by Cook is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K031766 ↗
Decision Date
June 26, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ATB All-Terrain Balloon PTA Dilatation Catheter was cleared through the FDA 510(k) pathway on June 26, 2003. Manufactured by Cook, it is classified as a Class 2 medical device.
What It Is
The ATB All-Terrain Balloon PTA Dilatation Catheter is a specialized catheter designed for percutaneous transluminal angioplasty. It features a balloon that can be inflated to widen narrowed or obstructed blood vessels, improving blood flow. This device is particularly useful in treating peripheral arterial disease and other vascular conditions.
Clinical Applications
This catheter is commonly used in procedures involving the dilation of peripheral arteries, such as those in the legs, to treat conditions like peripheral artery disease. It is typically employed in hospital settings, particularly in interventional radiology and vascular surgery departments. Patients who benefit from this device often suffer from symptoms of reduced blood flow, such as claudication.
Indications for Use
The FDA-cleared indications for this device include its use in dilating narrowed blood vessels to improve blood flow. It is suitable for patients with peripheral arterial disease or other conditions causing vessel stenosis.
Practical Considerations
The ATB All-Terrain Balloon PTA Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful technique to ensure proper placement and inflation. Clinicians should be familiar with angioplasty procedures and device handling.
Frequently Asked Questions
What is the ATB All-Terrain Balloon PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed blood vessels and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for dilating narrowed blood vessels in patients with conditions like peripheral arterial 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.