đź“‹ FDA Reference
modification to amphirion deep 0 014 otw pta balloon catheter
Invatec Innovative Technologies, S.R.L.
Summary: The Amphirion Deep 0 014 OTW PTA Balloon Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures, primarily by interventional radiologists and vascular surgeons to treat venous conditions.
FDA Clearance Information
Pathway
510K
Number
K050073 ↗
Decision Date
February 11, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amphirion Deep 0 014 OTW PTA Balloon Catheter was cleared by the FDA via the 510(k) pathway on February 11, 2005. It is manufactured by Invatec Innovative Technologies, S.R.L., and is classified as a Class 2 device under product code DQY.
What It Is
The Amphirion Deep 0 014 OTW PTA Balloon Catheter is designed for use in percutaneous transluminal angioplasty procedures. It functions by inflating a balloon within a blood vessel to open up narrowed or blocked sections, improving blood flow. This device is particularly useful in treating peripheral vascular disease, especially in the deep veins.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat conditions such as deep vein thrombosis or chronic venous insufficiency. The device is suitable for use in both hospital and outpatient settings, catering to adult patients with venous blockages.
Indications for Use
The FDA-cleared indications for this device include use in procedures aimed at dilating narrowed or obstructed venous pathways. It is particularly indicated for patients with peripheral vascular disease affecting the deep veins.
Practical Considerations
The Amphirion Deep 0 014 OTW PTA Balloon Catheter typically comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful handling to avoid vessel trauma during insertion and inflation.
Frequently Asked Questions
What is the Amphirion Deep 0 014 OTW PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to treat narrowed or blocked veins, improving blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in dilating narrowed or obstructed venous pathways, particularly in patients with peripheral 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.