đź“‹ FDA Reference
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. It is primarily used by interventional radiologists and vascular surgeons to treat vascular obstructions.
FDA Clearance Information
Pathway
510K
Number
K083919 ↗
Decision Date
March 13, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amphirion Deep 0 014 OTW PTA Balloon Catheter was cleared via the FDA 510(k) pathway on March 13, 2009. Manufactured by Invatec Innovative Technologies, S.R.L., it is a Class 2 device under product code DQY.
What It Is
The Amphirion Deep 0 014 OTW PTA Balloon Catheter is designed for percutaneous transluminal angioplasty (PTA) procedures. It functions by inflating a balloon within a blood vessel to widen narrowed or obstructed areas, improving blood flow. This device is particularly useful in treating peripheral arterial disease (PAD) and is compatible with over-the-wire (OTW) systems.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings to address peripheral arterial disease, especially in the lower extremities. It is suitable for use in hospitals and specialized clinics where endovascular procedures are performed. Patients with conditions such as claudication or critical limb ischemia may benefit from its use.
Indications for Use
The FDA indications for this device include treating narrowed or blocked blood vessels, typically in the peripheral arteries. It is intended for patients with conditions like peripheral arterial disease, where restoring blood flow is critical.
Practical Considerations
The Amphirion Deep 0 014 OTW PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters. It is important to ensure compatibility with the guidewire and other procedural equipment. Proper technique in balloon inflation and deflation is crucial to avoid vessel damage.
Frequently Asked Questions
What is Amphirion Deep 0 014 OTW PTA Balloon 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 typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is cleared for use in treating narrowed or obstructed 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.