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admiral xtreme pta catheter
Invatec Innovative Technologies
Summary: The Admiral Xtreme PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K062809 ↗
Decision Date
October 18, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Admiral Xtreme PTA Catheter was cleared through the FDA 510(k) pathway on October 18, 2006. Manufactured by Invatec Innovative Technologies, it is classified as a Class 2 device under product code DQY.
What It Is
The Admiral Xtreme PTA Catheter is designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. It consists of a flexible catheter with a balloon at its tip, which can be inflated to dilate the vessel. This device is particularly useful in treating peripheral artery disease and improving blood flow in affected limbs.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat peripheral artery disease, especially in the lower extremities. The device is suitable for patients with narrowed or blocked arteries due to atherosclerosis, and it is often used in outpatient or hospital settings.
Indications for Use
The FDA indications for the Admiral Xtreme PTA Catheter include its use in dilating stenotic segments of peripheral arteries. It is intended for patients with peripheral vascular disease to improve blood flow and alleviate symptoms such as claudication.
Practical Considerations
The Admiral Xtreme PTA Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with angioplasty techniques and consider vessel anatomy when selecting the appropriate catheter size.
Related Literature
The AcoArt III study focused on the use of the Admiral Xtreme PTA Catheter in arterio-venous fistula procedures in China. Although the abstract is not available, the study likely evaluated the device's effectiveness and safety in this specific application. Limitations may include the lack of detailed results and the study's geographic focus, which may affect generalizability.
Frequently Asked Questions
What is the Admiral Xtreme PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or blocked peripheral arteries.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
It is indicated for dilating stenotic segments of peripheral arteries to improve blood flow.
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.