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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. It is primarily utilized by interventional radiologists and vascular surgeons to treat venous stenosis.
FDA Clearance Information
Pathway
510K
Number
K052791 ↗
Decision Date
November 4, 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 510(k) pathway on November 4, 2005, by Invatec Innovative Technologies, S.R.L. It is classified as a Class 2 device under product code DQY.
What It Is
The Amphirion Deep 0.014 OTW PTA Balloon Catheter is a specialized catheter designed for use in percutaneous transluminal angioplasty (PTA) procedures. It features an over-the-wire (OTW) design that allows for precise navigation through blood vessels. The balloon can be inflated to dilate narrowed sections of veins, improving blood flow and reducing symptoms associated with venous stenosis.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for the treatment of venous stenosis, particularly in the lower extremities. It is suitable for patients with peripheral artery disease (PAD) or those requiring venous stenting. The catheter is often employed in outpatient or hospital-based catheterization labs.
Indications for Use
The FDA-cleared indications for this device include the treatment of narrowed or blocked veins, particularly in patients with conditions like peripheral artery disease. It is designed to restore proper blood flow by dilating the affected vessel.
Practical Considerations
The Amphirion Deep 0.014 OTW PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful technique to ensure proper placement and inflation. Clinicians should be familiar with the catheter's specifications and handling instructions.
Frequently Asked Questions
What is Amphirion Deep 0.014 OTW PTA Balloon Catheter used for?
It is used for percutaneous transluminal angioplasty (PTA) to treat venous stenosis.
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 the treatment of narrowed or blocked veins 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.