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nanocorss 014 otw pta dilatation catheter
Ev3
Summary: The Nanocross 014 OTW PTA Dilatation 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 stenosis.
FDA Clearance Information
Pathway
510K
Number
K082854 ↗
Decision Date
December 4, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Nanocross 014 OTW PTA Dilatation Catheter was cleared via the FDA 510(k) pathway on December 4, 2008. Manufactured by Ev3, it is a Class 2 device under product code DQY.
What It Is
The Nanocross 014 OTW PTA Dilatation Catheter is a specialized catheter designed for over-the-wire (OTW) use in percutaneous transluminal angioplasty (PTA). It is used to dilate narrowed sections of blood vessels, particularly in the peripheral vasculature. The device works by inflating a balloon at the site of stenosis to restore adequate blood flow.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD), particularly in the lower extremities. It is often employed in settings such as interventional radiology suites and vascular surgery departments. The device is suitable for adult patients with vascular stenosis requiring endovascular intervention.
Indications for Use
The FDA-cleared indications for this device include use in procedures to open narrowed blood vessels in patients with peripheral artery disease. It is intended for use in patients who require balloon angioplasty to improve blood flow.
Practical Considerations
The Nanocross 014 OTW PTA Dilatation Catheter is available in various balloon sizes to accommodate different vessel diameters. It is compatible with standard 0.014-inch guidewires and requires careful handling to ensure proper placement and inflation during procedures.
Frequently Asked Questions
What is the Nanocross 014 OTW PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels, particularly in peripheral artery disease.
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 procedures to open narrowed blood vessels in patients with peripheral artery 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.