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modification to numed tyshak ii and z-med ii ptv catheters
Numed
Summary: The Tyshak II and Z-Med II PTV Catheters are balloon catheters used for percutaneous transluminal valvuloplasty and angioplasty procedures. They are utilized by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K030589 ↗
Decision Date
May 21, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Tyshak II and Z-Med II PTV Catheters, manufactured by Numed, were cleared via the FDA 510(k) pathway on May 21, 2003. They are classified as Class 2 devices under product code DQY.
What It Is
The Tyshak II and Z-Med II PTV Catheters are balloon catheters designed for percutaneous transluminal procedures. These catheters are used to dilate stenotic valves or vessels, improving blood flow. They are made with a flexible material that allows for precise navigation through the vascular system, and the balloon can be inflated to various sizes to accommodate different anatomical needs.
Clinical Applications
These catheters are commonly used in interventional cardiology and radiology for procedures such as valvuloplasty, where they help to open narrowed heart valves, and angioplasty, where they dilate narrowed blood vessels. They are particularly useful in pediatric and adult patients with congenital or acquired heart valve stenosis or vascular obstructions. The procedures are typically performed in a catheterization lab setting.
Indications for Use
The FDA-cleared indications for these catheters include use in patients with stenotic heart valves or blood vessels that require dilation. They are suitable for both congenital and acquired conditions that result in narrowed pathways, affecting blood flow.
Practical Considerations
These catheters are available in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard guidewires and sheaths used in catheterization procedures. Clinicians should be familiar with the inflation techniques and pressure limits to ensure safe and effective use.
Frequently Asked Questions
What is Tyshak II and Z-Med II PTV Catheters used for?
They are used for dilating stenotic heart valves and blood vessels in procedures like valvuloplasty and angioplasty.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use these catheters.
What are the FDA-cleared indications?
They are indicated for use in patients with stenotic heart valves or blood vessels requiring dilation.
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.