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numed high pressure pta catheters
Numed
Summary: Numed High Pressure PTA Catheters are used in angioplasty procedures to dilate blood vessels. They are primarily used by interventional radiologists and cardiologists to treat vascular conditions.
FDA Clearance Information
Pathway
510K
Number
K010880 ↗
Decision Date
April 20, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Numed High Pressure PTA Catheters were cleared through the FDA 510(k) pathway on April 20, 2001. Manufactured by Numed, this device is classified as Class 2 under product code DQY.
What It Is
The Numed High Pressure PTA Catheters are medical devices used in percutaneous transluminal angioplasty (PTA) procedures. These catheters are designed to withstand high pressures, allowing for effective dilation of stenotic or obstructed blood vessels. They are typically used in vascular interventions to improve blood flow in arteries or veins.
Clinical Applications
These catheters are commonly used in interventional radiology and cardiology settings for procedures such as treating peripheral artery disease or venous obstructions. They are suitable for use in both hospital and outpatient settings, and are often employed in patients with atherosclerosis or other vascular conditions requiring vessel dilation.
Indications for Use
The FDA indications for this device include use in procedures to dilate narrowed or blocked blood vessels. This is particularly relevant for patients with conditions like peripheral artery disease or venous stenosis.
Practical Considerations
Numed High Pressure PTA Catheters come in various sizes to accommodate different vessel diameters and lengths. They are compatible with standard angioplasty equipment and require careful handling to avoid vessel damage during inflation.
Frequently Asked Questions
What is Numed High Pressure PTA Catheters used for?
They are used to dilate narrowed or blocked blood vessels during angioplasty procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in dilating stenotic or obstructed blood vessels.
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.