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bard atlas pta balloon dilatation catheter
C.R. Bard
Summary: The Bard Atlas PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is typically used by interventional radiologists and vascular surgeons to treat venous stenosis.
FDA Clearance Information
Pathway
510K
Number
K040243 ↗
Decision Date
February 13, 2004
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 February 13, 2004. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DQY.
What It Is
The Bard Atlas PTA Balloon Dilatation Catheter is designed for use in percutaneous transluminal angioplasty (PTA) to dilate stenotic segments of blood vessels. It consists of a balloon catheter that is inserted into the vessel and inflated to open up narrowed areas, improving blood flow. This device is particularly useful in treating venous stenosis, especially in dialysis access circuits.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat stenotic lesions in veins, particularly in patients with arteriovenous (AV) fistulas or grafts for hemodialysis. The catheter is used in hospitals and outpatient centers, primarily for patients with chronic kidney disease requiring dialysis.
Indications for Use
The FDA-cleared indications for this device include the dilation of stenotic segments in veins, particularly in patients with dialysis access issues. It is intended for use in patients who have developed narrowing in their blood vessels, which can impede blood flow and affect dialysis efficiency.
Practical Considerations
The Bard Atlas PTA Balloon Dilatation Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with the technique of balloon angioplasty and consider vessel size and lesion characteristics when selecting the appropriate balloon size.
Frequently Asked Questions
What is the Bard Atlas PTA Balloon Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed segments of blood vessels, particularly in venous stenosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for the dilation of stenotic segments in veins, especially in patients with dialysis access issues.
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.