📋 FDA Reference
Armada 14xxt PTA Catheter
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 ?
510(k)
Number ?
K121352 ↗
Decision Date ?
August 15, 2012
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Dilation of stenotic lesions in peripheral blood vessels.
- Percutaneous transluminal angioplasty of the peripheral vasculature.
- Treatment of peripheral vascular disease when balloon dilation is clinically indicated.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of atherosclerotic stenoses in the leg arteries.
- Percutaneous treatment of peripheral vascular disease in adult patients.
- Dilation of peripheral vascular lesions using fluoroscopic catheter guidance.
Practical Considerations
- The catheter is available in multiple balloon diameters and working lengths; the appropriate size depends on the vessel diameter and lesion length.
- It is used over a compatible guidewire through an introducer sheath, with balloon inflation and deflation performed according to the device instructions for use.
- Use requires fluoroscopic imaging and trained clinicians familiar with peripheral angioplasty, balloon pressures and management of vascular complications.
- MRI safety and conditions depend on the specific catheter model and labeling; the device should not be assumed to be MRI safe without reviewing the current manufacturer instructions.
- Contraindications, warnings and balloon inflation limits should be checked in the current Abbott instructions for use before treatment.
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.