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navajo pta balloon dilatation catheter
Curative Medical
Summary: The Navajo PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty to treat vascular stenosis. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K141354 ↗
Decision Date
January 30, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Navajo PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on January 30, 2015. Manufactured by Curative Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Navajo PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA) procedures. It consists of a balloon at the tip of a catheter, which is inserted into a narrowed or blocked blood vessel. The balloon is then inflated to widen the vessel, improving blood flow. This device is crucial in treating vascular conditions such as peripheral artery disease.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Navajo PTA Balloon Dilatation Catheter is employed in procedures to treat stenosis in peripheral arteries. It is suitable for use in hospital settings, particularly in catheterization labs, and is often used in patients with atherosclerosis or other vascular diseases that cause narrowing of blood vessels.
Indications for Use
The device is indicated for use in patients with vascular stenosis, where it helps to dilate narrowed blood vessels. It is particularly useful in treating peripheral artery disease, improving blood flow and reducing symptoms such as claudication.
Practical Considerations
The catheter comes in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be trained in catheterization techniques and aware of potential complications such as vessel dissection or rupture.
Frequently Asked Questions
What is the Navajo PTA Balloon Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to treat 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 dilating narrowed blood vessels in patients with vascular stenosis, such as those 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.