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pheron pta catheter
Biotronik
Summary: The Pheron PTA Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures, primarily by interventional radiologists and cardiologists to treat vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K033217 ↗
Decision Date
October 31, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Pheron PTA Catheter was cleared through the FDA 510(k) pathway on October 31, 2003. It is manufactured by Biotronik and classified as a Class II device under product code DQY.
What It Is
The Pheron PTA Catheter is designed for percutaneous transluminal angioplasty, a procedure to open narrowed or blocked blood vessels. It works by inflating a balloon at the site of the stenosis to compress the plaque against the vessel wall, improving blood flow. This device is typically used in peripheral vascular interventions.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Pheron PTA Catheter is employed in procedures to treat peripheral artery disease (PAD) and other vascular obstructions. It is suitable for use in both hospital and outpatient settings, often in patients with atherosclerosis or other conditions causing vessel narrowing.
Indications for Use
The FDA indications for the Pheron PTA Catheter include its use in treating patients with vascular stenosis, where it helps to restore adequate blood flow. It is particularly indicated for peripheral vascular interventions.
Practical Considerations
The Pheron PTA Catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and requires careful technique to ensure proper placement and inflation during procedures.
Frequently Asked Questions
What is the Pheron PTA Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or blocked blood vessels.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for treating vascular stenosis to improve blood flow in 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.