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numed tyshak mini pediatric ptv catheter
Numed
Summary: The Numed Tyshak Mini Pediatric PTV Catheter is a balloon catheter used in pediatric patients for percutaneous transluminal valvuloplasty (PTV). It is primarily used by interventional cardiologists in pediatric settings.
FDA Clearance Information
Pathway
510K
Number
K032591 ↗
Decision Date
September 25, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Numed Tyshak Mini Pediatric PTV Catheter was cleared via the FDA 510(k) pathway on September 25, 2003. Manufactured by Numed, it is classified as a Class 2 device under product code DQY.
What It Is
The Numed Tyshak Mini Pediatric PTV Catheter is a specialized balloon catheter designed for use in pediatric patients. It is used to dilate stenotic heart valves via percutaneous transluminal valvuloplasty. The catheter's design allows for precise control and effective dilation, which is crucial in the delicate anatomy of pediatric patients. Its construction ensures compatibility with small vessel sizes and provides reliable performance during procedures.
Clinical Applications
This catheter is commonly used in pediatric cardiology for procedures involving the dilation of stenotic heart valves. It is typically employed in hospital settings, particularly in catheterization labs. The device is used by interventional cardiologists to treat congenital heart defects in infants and children, providing a minimally invasive option to improve valve function and blood flow.
Indications for Use
The FDA-cleared indications for this device include use in pediatric patients requiring dilation of stenotic heart valves. It is specifically designed for conditions where valve narrowing impedes normal blood flow, necessitating intervention to restore adequate circulation.
Practical Considerations
The Tyshak Mini is available in various sizes to accommodate different patient anatomies, ensuring a proper fit for effective treatment. Clinicians should be familiar with the catheter's compatibility with standard guidewires and introducer sheaths. Proper technique during insertion and inflation is critical to avoid complications and achieve optimal outcomes.
Frequently Asked Questions
What is the Numed Tyshak Mini Pediatric PTV Catheter used for?
It is used for percutaneous transluminal valvuloplasty in pediatric patients to dilate stenotic heart valves.
What specialties typically use this device?
Interventional cardiologists, particularly those specializing in pediatric cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in pediatric patients requiring dilation of stenotic heart valves to improve blood flow.
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.