đź“‹ FDA Reference
nucleus-x model 230x
Numed
Summary: The Nucleus-X Model 230x is a venous stent used to treat venous obstructions. It is primarily utilized by interventional radiologists and vascular surgeons to improve blood flow in patients with venous insufficiency.
FDA Clearance Information
Pathway
510K
Number
K081680 ↗
Decision Date
July 10, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Nucleus-X Model 230x received FDA clearance through the 510(k) pathway on July 10, 2008. Manufactured by Numed, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Nucleus-X Model 230x is a self-expanding venous stent designed to maintain patency in veins that have become narrowed or obstructed. It is typically made of a metal mesh that expands once deployed in the vein, providing structural support to the vessel wall and improving blood flow. This device is crucial in managing conditions like chronic venous insufficiency and post-thrombotic syndrome.
Clinical Applications
This device is commonly used in procedures to treat venous obstructions, particularly in the iliac and femoral veins. Interventional radiologists and vascular surgeons often deploy these stents in hospital settings or specialized vascular centers. Patients who benefit from this device typically suffer from conditions like deep vein thrombosis or chronic venous insufficiency, where maintaining venous patency is critical.
Indications for Use
The Nucleus-X Model 230x is indicated for patients with venous obstructions that impair blood flow, such as those caused by chronic venous insufficiency or post-thrombotic syndrome. It is used to restore and maintain proper venous circulation.
Practical Considerations
The Nucleus-X Model 230x comes in various sizes to accommodate different vein diameters and lengths. It is compatible with standard delivery systems used in venous interventions. Clinicians should be familiar with deployment techniques to ensure optimal placement and expansion of the stent.
Frequently Asked Questions
What is Nucleus-X Model 230x used for?
It is used to treat venous obstructions by providing structural support to veins, improving blood flow in conditions like chronic venous insufficiency.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in hospital or specialized vascular settings.
What are the FDA-cleared indications?
It is indicated for patients with venous obstructions that impair blood flow, such as those with chronic venous insufficiency or post-thrombotic syndrome.
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.