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atb advanced pta dilatation catheter
Cook
Summary: The atb advanced pta dilatation catheter by Cook 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
K063252 ↗
Decision Date
November 14, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The atb advanced pta dilatation catheter was cleared through the FDA 510(k) pathway on November 14, 2006. Manufactured by Cook, it is classified as a Class 2 device under product code DQY.
What It Is
The atb advanced pta dilatation catheter is designed to dilate stenotic segments of blood vessels, typically in the peripheral vascular system. It consists of a balloon that can be inflated to widen the vessel, improving blood flow. This device is crucial in treating conditions like peripheral artery disease, where blood vessels become narrowed or blocked.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat peripheral artery disease, often in outpatient or hospital settings. Patients who benefit from this device typically have conditions that lead to narrowed or obstructed blood vessels, such as atherosclerosis.
Indications for Use
The FDA indications suggest that this catheter is intended for use in patients with narrowed blood vessels that require widening to restore adequate blood flow. It is particularly useful in treating peripheral vascular diseases.
Practical Considerations
Clinicians should consider the size of the vessel and the extent of the stenosis when selecting the appropriate catheter size. Compatibility with existing guidewires and sheaths is important for successful deployment. Proper technique is essential to avoid complications such as vessel dissection or rupture.
Frequently Asked Questions
What is atb advanced pta dilatation catheter used for?
It is used for dilating narrowed blood vessels in procedures such as percutaneous transluminal angioplasty.
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 stenotic segments of blood vessels to improve blood flow, particularly in 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.