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mini ghost model 507
Numed
Summary: The mini ghost model 507 is a venous stent used to support veins in patients with venous insufficiency or obstruction. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K082524 ↗
Decision Date
September 26, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The mini ghost model 507, manufactured by Numed, was cleared through the FDA 510k pathway on September 26, 2008. It is classified as a Class 2 medical device under product code DQY.
What It Is
The mini ghost model 507 is a venous stent designed to provide structural support to veins, particularly in cases of venous insufficiency or obstruction. It is made to be inserted into the vein to keep it open, ensuring proper blood flow. This device is crucial in managing conditions where veins are narrowed or blocked, helping to prevent complications such as swelling or ulceration.
Clinical Applications
This device is commonly used in procedures involving the treatment of chronic venous insufficiency or post-thrombotic syndrome. Interventional radiologists and vascular surgeons often employ it in hospital settings or specialized vascular centers. It is particularly beneficial for patients with a history of deep vein thrombosis or those who have developed venous obstructions.
Indications for Use
The mini ghost model 507 is indicated for patients with venous blockages or narrowing, which can lead to poor blood flow and related complications. It is suitable for individuals experiencing symptoms of venous insufficiency, such as leg swelling or pain.
Practical Considerations
The mini ghost model 507 comes in various sizes to accommodate different vein diameters. It is compatible with standard delivery systems used in vascular interventions. Clinicians should be familiar with the insertion technique to ensure optimal placement and function.
Frequently Asked Questions
What is mini ghost model 507 used for?
It is used to support veins in patients with venous insufficiency or obstruction, ensuring proper blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients with venous blockages or narrowing, particularly in cases of venous insufficiency.
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.