đź“‹ FDA Reference
armada 14xxt pta catheter
Abbott Vascular
Summary: The Armada 14XXT PTA Catheter is a percutaneous transluminal angioplasty catheter used primarily by interventional radiologists and vascular surgeons to treat vascular stenosis. It is designed for use in peripheral vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K121352 ↗
Decision Date
August 15, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Armada 14XXT PTA Catheter was cleared through the FDA 510(k) pathway on August 15, 2012. It is manufactured by Abbott Vascular and classified as a Class 2 medical device.
What It Is
The Armada 14XXT PTA Catheter is a medical device used in percutaneous transluminal angioplasty (PTA) procedures. It is designed to dilate narrowed or obstructed blood vessels in the peripheral vasculature. The catheter features a balloon that can be inflated to open up stenotic areas, improving blood flow. Its design allows for precise navigation and placement within the vascular system.
Clinical Applications
This catheter is commonly used in the treatment of peripheral artery disease (PAD) to restore blood flow in the legs and other peripheral arteries. It is typically employed in interventional radiology and vascular surgery settings. The device is suitable for adult patients with atherosclerotic disease and is often used in outpatient or hospital-based procedures.
Indications for Use
The Armada 14XXT PTA Catheter is indicated for use in patients with peripheral vascular disease to dilate stenotic segments of blood vessels. It is particularly useful in treating conditions that cause narrowing of the arteries, such as atherosclerosis.
Practical Considerations
The catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with the catheter's inflation and deflation techniques to ensure optimal results.
Related Literature
The linked study explored the in situ laser fenestration technique in aortic endografts, assessing its feasibility and effectiveness. The study found that this technique could enable total endovascular treatment of complex aortic pathologies. However, the study was limited to bench-testing, and further clinical trials are necessary to validate these findings in real-world settings.
Frequently Asked Questions
What is the Armada 14XXT PTA Catheter used for?
It is used for dilating narrowed or obstructed peripheral arteries to restore blood flow, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in peripheral vascular interventions.
What are the FDA-cleared indications?
The catheter is indicated for use in dilating stenotic segments of peripheral arteries in patients with 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.