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numed z-med ptv catherers
Numed
Summary: The Numed Z-Med PTV Catheters are balloon catheters used for percutaneous transluminal angioplasty (PTA) procedures. They are primarily utilized by interventional cardiologists and radiologists to treat vascular stenosis.
FDA Clearance Information
Pathway
510K
Number
K003643 ↗
Decision Date
December 27, 2000
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Numed Z-Med PTV Catheters were cleared through the FDA 510(k) pathway on December 27, 2000. Manufactured by Numed, this Class 2 device is categorized under product code DQY.
What It Is
The Numed Z-Med PTV Catheters are specialized balloon catheters designed for use in percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. These catheters are equipped with a balloon that can be inflated to open up stenotic segments of veins or arteries, improving blood flow. They are made from materials that provide flexibility and strength, allowing them to navigate through the vascular system effectively.
Clinical Applications
These catheters are commonly used in interventional cardiology and radiology for procedures involving the dilation of stenotic vessels, such as in cases of peripheral artery disease or venous obstructions. They are often used in hospital settings, particularly in catheterization labs, and are suitable for adult and pediatric patients with vascular stenosis. The device's design allows it to be used in various vascular territories, making it versatile for different clinical scenarios.
Indications for Use
The FDA indications for the Numed Z-Med PTV Catheters involve their use in procedures aimed at dilating narrowed blood vessels. This is particularly relevant for patients with conditions like peripheral artery disease, where vessel narrowing can impede blood flow.
Practical Considerations
These catheters come in various sizes to accommodate different vessel diameters and lengths. They are compatible with standard guidewires and sheaths used in PTA procedures. Clinicians should ensure proper sizing and inflation techniques to optimize outcomes and minimize complications.
Frequently Asked Questions
What is Numed Z-Med PTV Catheters used for?
They are used for percutaneous transluminal angioplasty to dilate narrowed blood vessels.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in dilating narrowed blood vessels, such as in 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.