📋 FDA Reference
Nucleus-X Model 230x
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 ?
510(k)
Number ?
K081680 ↗
Decision Date ?
July 10, 2008
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record provided identifies the device under product code DQY, Catheter, Percutaneous, classified under 21 CFR 870.1250.
- The supplied FDA indication field contains only “Summary” and does not provide a complete indication-for-use statement.
Clinical Applications
- Use as a percutaneous catheter-based device within the scope of the complete FDA-cleared labeling.
- Clinical applications should be confirmed against the original 510(k) summary, indications for use, and current manufacturer instructions before use.
Practical Considerations
- The supplied record does not verify the device design, whether it is self-expanding, or whether it is specifically intended for venous stenting.
- Device sizes, delivery-system compatibility, deployment instructions, and handling requirements should be taken from the manufacturer’s current instructions for use.
- MRI safety and conditional-use requirements cannot be determined from the supplied FDA record; review the device labeling before MRI.
- Contraindications, warnings, anticoagulation requirements, and required imaging guidance should be confirmed in the FDA-cleared labeling.
- The existing description should not be used to infer iliac, femoral, central-vein, chronic venous insufficiency, post-thrombotic syndrome, or deep-vein-thrombosis indications without verifying the original labeling.
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.