📋 FDA Reference
Tyshak Nucleus
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 ?
510(k)
Number ?
K121859 ↗
Decision Date ?
August 31, 2012
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous dilation of stenotic blood vessels.
- Use during catheter-based treatment of vascular narrowing when balloon angioplasty is indicated.
Clinical Applications
- Balloon angioplasty of narrowed venous vessels.
- Dilation of vessel stenosis associated with congenital heart disease.
- Dilation of acquired vascular narrowing during an interventional cardiology or vascular procedure.
- Catheter-based treatment of stenosis in appropriately sized vessels selected by the treating clinician.
Reported off-label uses
- Use in selected noncoronary arterial or venous lesions outside the specific device labeling may occur in clinical practice, but this should be determined by the treating physician and is not an FDA-cleared indication for every anatomy or application.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is available in multiple balloon diameters and lengths; the selected size must match the target vessel and the manufacturer's specifications.
- It is used through percutaneous vascular access with fluoroscopic or other appropriate imaging guidance and requires standard balloon-catheter inflation equipment.
- Clinicians should follow the current instructions for use for inflation pressure, guidewire compatibility, preparation, and handling.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume that the catheter is safe during MRI.
- General balloon-angioplasty risks include vessel injury, dissection, rupture, thrombosis, embolization, bleeding, infection, and restenosis. Contraindications and precautions depend on the target vessel, lesion, access site, and patient's clinical condition.
Procedures that use this device
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.