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atb all-terrain balloon pta dilatation catheter
Cook
Summary: The ATB All-Terrain Balloon PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed or obstructed blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K033875 ↗
Decision Date
April 2, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ATB All-Terrain Balloon PTA Dilatation Catheter was cleared by the FDA through the 510(k) pathway on April 2, 2004. It is manufactured by Cook and classified as a Class 2 medical device under product code DQY.
What It Is
The ATB All-Terrain Balloon PTA Dilatation Catheter is designed for use in percutaneous transluminal angioplasty procedures. It features a balloon that can be inflated to dilate narrowed or blocked blood vessels, improving blood flow. This device is particularly useful in treating peripheral vascular disease and is engineered to navigate challenging vascular anatomy.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease, especially in the lower extremities. Interventional radiologists and vascular surgeons use it in hospital settings or outpatient surgical centers. It is suitable for patients with atherosclerotic lesions or other conditions causing vascular stenosis.
Indications for Use
The FDA indications suggest this device is intended for use in dilating stenotic segments of blood vessels. It is particularly beneficial for patients with peripheral vascular disease requiring intervention to restore adequate blood flow.
Practical Considerations
The 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 be familiar with the device's inflation and deflation techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the ATB All-Terrain Balloon PTA Dilatation Catheter used for?
It is used for dilating narrowed or obstructed blood vessels in percutaneous transluminal angioplasty procedures.
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 stenotic segments of blood vessels, particularly in patients with peripheral vascular 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.