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foxcross 035 pta catheter 14 mm x 20mm x 80 cm model 10342-20 foxcross 035 pta catheter
Abbott Vascular-Vascular Solutions
Summary: The foxcross 035 PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to treat vascular stenosis. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K090509 ↗
Decision Date
March 20, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The foxcross 035 PTA Catheter was cleared through the FDA 510k pathway on March 20, 2009. Manufactured by Abbott Vascular-Vascular Solutions, it is classified as a Class 2 device.
What It Is
The foxcross 035 PTA Catheter is designed for percutaneous transluminal angioplasty procedures. It features a balloon that can be inflated to dilate narrowed blood vessels, improving blood flow. This catheter is specifically engineered for use in larger vessels, such as those found in the peripheral vascular system.
Clinical Applications
This device is commonly used in procedures addressing peripheral artery disease, particularly in the legs. It is utilized in settings such as hospitals and outpatient surgical centers by specialists in interventional radiology and vascular surgery. The catheter is suitable for patients with vascular stenosis requiring endovascular intervention.
Indications for Use
The FDA-cleared indications for the foxcross 035 PTA Catheter include its use in treating vascular stenosis, which involves narrowing of the blood vessels. It is intended for patients who need angioplasty to restore adequate blood flow in peripheral arteries.
Practical Considerations
The foxcross 035 PTA Catheter is available in various sizes to accommodate different vessel diameters and lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should consider vessel size and lesion characteristics when selecting the appropriate catheter size.
Frequently Asked Questions
What is the foxcross 035 PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed blood vessels, improving blood flow in patients with vascular stenosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in treating vascular stenosis, specifically for dilating narrowed peripheral arteries.
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.