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bard atlas pta balloon dilatation catheter
Bard Peripheral Vascular
Summary: The Bard Atlas PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat vascular stenosis. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K052236 ↗
Decision Date
August 23, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bard Atlas PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on August 23, 2005. Manufactured by Bard Peripheral Vascular, it is classified as a Class II device.
What It Is
The Bard Atlas PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. The catheter features a balloon that can be inflated to compress plaque against the vessel wall, improving blood flow. This device is particularly useful in treating peripheral vascular disease and is compatible with a range of guidewires and sheaths.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings to treat patients with peripheral artery disease, especially in the lower extremities. It is suitable for use in outpatient and inpatient settings, and can be employed in both elective and emergency procedures. The device is often used in patients with atherosclerosis to restore adequate blood flow and alleviate symptoms such as claudication.
Indications for Use
The FDA indications for the Bard Atlas PTA Balloon Dilatation Catheter include use in patients with vascular stenosis, particularly in peripheral arteries. It is intended to improve blood flow in patients with narrowed or blocked vessels.
Practical Considerations
The Bard Atlas PTA Balloon Dilatation Catheter is available in various sizes to accommodate different vessel diameters. It is important to select the appropriate size for the target vessel to ensure effective dilation. Clinicians should be familiar with the device's compatibility with other interventional tools and follow proper technique to minimize complications.
Frequently Asked Questions
What is the Bard Atlas PTA Balloon Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to treat vascular stenosis and improve blood flow.
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 use in patients with vascular stenosis, particularly in peripheral arteries, to improve blood flow.
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.