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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. It is primarily utilized by interventional radiologists and vascular surgeons to treat vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K042624 ↗
Decision Date
January 10, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amphirion Deep 0 014 OTW PTA Balloon Catheter was cleared through the FDA 510k pathway on January 10, 2005. Manufactured by Invatec Innovative Technologies, S.R.L., it is classified as a Class 2 medical device.
What It Is
The Amphirion Deep 0 014 OTW PTA Balloon Catheter is designed for use in percutaneous transluminal angioplasty procedures. It is a catheter with a balloon at its tip that can be inflated to open up narrowed or blocked blood vessels, improving blood flow. The device is over-the-wire (OTW), meaning it is guided to the target site using a guidewire, which provides precision in positioning.
Clinical Applications
This device is commonly used in interventional procedures to treat peripheral arterial disease (PAD) and other vascular conditions. It is typically used in hospital settings, particularly in interventional radiology and vascular surgery departments. Patients who benefit from this device often have conditions such as atherosclerosis, where blood vessels are narrowed due to plaque buildup.
Indications for Use
The FDA indications suggest that this device is intended for use in patients with vascular conditions requiring angioplasty to restore blood flow. It is particularly useful for treating narrowed or blocked arteries in the peripheral vasculature.
Practical Considerations
The Amphirion Deep 0 014 OTW PTA Balloon Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful handling to ensure precise placement and inflation during procedures.
Frequently Asked Questions
What is the Amphirion Deep 0 014 OTW PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty to open narrowed or blocked blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in angioplasty procedures to treat vascular conditions such as peripheral arterial 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.