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tyshak nucleus
Numed
Summary: The Tyshak Nucleus is a balloon catheter used in interventional cardiology for dilating stenotic vessels. It is primarily utilized by cardiologists in catheterization labs.
FDA Clearance Information
Pathway 510K
Number K121859 ↗
Decision Date August 31, 2012
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Tyshak Nucleus, manufactured by Numed, was cleared through the FDA 510(k) pathway on August 31, 2012. It is a Class 2 device under product code DQY.
What It Is
The Tyshak Nucleus is a specialized balloon catheter designed for the dilation of stenotic vessels, particularly in venous applications. It features a unique design that allows for precise control and effective dilation. This device is often used in procedures requiring high precision, such as those involving delicate vascular structures.
Clinical Applications
Commonly used in interventional cardiology, the Tyshak Nucleus is employed during procedures to treat venous stenosis. It is particularly useful in pediatric and adult patients with congenital or acquired heart conditions requiring vessel dilation. The device is typically used in hospital catheterization labs by cardiologists and interventional radiologists.
Indications for Use
The FDA-cleared indications for the Tyshak Nucleus involve the dilation of stenotic vessels. It is suitable for patients with narrowed veins that require widening to improve blood flow, often due to congenital heart defects or other vascular conditions.
Practical Considerations
The Tyshak Nucleus comes in various sizes to accommodate different vessel diameters and patient needs. It is compatible with standard catheterization equipment, and clinicians should be familiar with balloon sizing and inflation techniques to ensure optimal outcomes.
Frequently Asked Questions
What is Tyshak Nucleus used for?
The Tyshak Nucleus is used for dilating stenotic vessels, particularly in venous applications.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the Tyshak Nucleus in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for the dilation of stenotic vessels to improve blood flow in patients with vascular conditions.
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.