đź“‹ FDA Reference
fox pta catheter 3 0 4 0 5 0 6 0 7 0 and 8 0 x 40 mm models a14003 a14004 a14005 a14006 a14007 a14008
Jomed Ag
Summary: The Fox PTA Catheter is a percutaneous transluminal angioplasty catheter used to treat vascular stenosis. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K010838 ↗
Decision Date
June 21, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Fox PTA Catheter by Jomed Ag was cleared via the FDA 510(k) pathway on June 21, 2001. It is a Class 2 medical device under product code DQY.
What It Is
The Fox PTA Catheter is a balloon catheter designed for percutaneous transluminal angioplasty (PTA). It is used to dilate narrowed or obstructed blood vessels, typically in the peripheral vasculature. The device comes in various sizes, allowing for flexibility in treating different vessel diameters.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD) and other conditions involving vascular stenosis. It is often employed in interventional radiology and vascular surgery settings. The device is suitable for use in adult patients who require vessel dilation to improve blood flow.
Indications for Use
The FDA indications suggest that the Fox PTA Catheter is intended for use in patients with narrowed blood vessels that need widening to restore adequate blood flow. This is particularly relevant for patients with peripheral artery disease.
Practical Considerations
The Fox PTA Catheter is available in sizes ranging from 3.0 to 8.0 mm in diameter, with a length of 40 mm. It is important to select the appropriate size based on the target vessel's diameter. Compatibility with other interventional tools should be verified prior to the procedure.
Frequently Asked Questions
What is the Fox PTA Catheter used for?
It is used for dilating narrowed or obstructed blood vessels in peripheral angioplasty procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for use in dilating narrowed blood vessels to improve blood flow, particularly in peripheral artery 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.