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conquest 40 pta dilatation catheter atlas gold pta dilatation catheter vida ptv dilatation catheter vida bav balloon valvuloplasty catheter
C.R. Bard
Summary: The Conquest 40, Atlas Gold, Vida PTV, and Vida BAV catheters are balloon dilatation devices used for percutaneous transluminal angioplasty (PTA) and valvuloplasty. They are primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K212588 ↗
Decision Date
May 4, 2022
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
These devices were cleared through the FDA 510(k) pathway on May 4, 2022, by C.R. Bard. They are classified as Class 2 devices under product code DQY.
What It Is
The Conquest 40, Atlas Gold, Vida PTV, and Vida BAV catheters are specialized balloon dilatation catheters designed for use in PTA and valvuloplasty procedures. These devices help to open narrowed or obstructed blood vessels and heart valves, improving blood flow. They are equipped with high-pressure balloons that can be inflated to dilate the vessel or valve, facilitating treatment of vascular diseases.
Clinical Applications
These catheters are commonly used in interventional radiology and cardiology settings for procedures such as treating peripheral artery disease, post-stent deployment dilatation, and balloon aortic valvuloplasty. They are suitable for use in adult patients with vascular stenosis or valvular heart disease. The devices are typically used in hospital catheterization labs or specialized vascular centers.
Indications for Use
The FDA indications suggest these catheters are intended for use in patients with narrowed blood vessels or heart valves. They are designed to dilate these areas to improve blood flow, often in cases of peripheral artery disease or valvular stenosis.
Practical Considerations
These catheters come in various sizes to accommodate different vessel diameters and anatomical locations. They are compatible with standard guidewires and sheaths used in vascular procedures. Proper technique involves careful navigation to the target site and controlled inflation to avoid vessel injury.
Frequently Asked Questions
What is Conquest 40 & Atlas Gold PTA Catheters used for?
These catheters are used for dilating narrowed blood vessels and heart valves to improve blood flow.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use these devices.
What are the FDA-cleared indications?
These devices are indicated for use in dilating narrowed blood vessels and heart valves in patients with vascular stenosis or valvular heart 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.