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bard conquest pta balloon dilatation catheter
C.R. Bard
Summary: The Bard Conquest PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty. It is typically used by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway
510K
Number
K014212 ↗
Decision Date
January 17, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bard Conquest PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on January 17, 2002. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DQY.
What It Is
The Bard Conquest PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA), a procedure to dilate narrowed or obstructed blood vessels. The catheter features a balloon that can be inflated to open up the vessel, improving blood flow. This device is particularly useful in treating peripheral vascular disease, where blood vessels outside the heart and brain become narrowed.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings to treat patients with peripheral artery disease (PAD) or other forms of vascular stenosis. It is often employed in hospitals and outpatient surgical centers, particularly for patients who have not responded to medical therapy. The device is suitable for adult patients experiencing symptoms related to reduced blood flow in the limbs.
Indications for Use
The FDA indications for this device include the treatment of narrowed blood vessels, particularly in the peripheral vasculature. It is intended for patients with conditions such as peripheral artery disease, where blood flow is restricted due to vessel narrowing.
Practical Considerations
The Bard Conquest PTA Balloon Dilatation Catheter comes 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 Conquest PTA Balloon 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 the treatment of narrowed blood vessels, particularly in the peripheral vasculature, such as in peripheral artery 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.