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Jiangxi Medex Technology
Summary: The SLT Select Fiber Delivery System is a medical device used in portal vein procedures. It is primarily utilized by interventional radiologists and vascular surgeons for precise delivery of therapeutic agents.
FDA Clearance Information
Pathway
510K
Number
K243121 ↗
Decision Date
December 22, 2024
Product Code
GEX
Device Class
Class 2
Evidence
0 studies
The SLT Select Fiber Delivery System by Jiangxi Medex Technology was cleared through the FDA 510(k) pathway on December 22, 2024. It is classified as a Class 2 device under product code GEX.
What It Is
The SLT Select Fiber Delivery System is a sophisticated device designed for the delivery of therapeutic agents into the portal vein. It consists of various fiber delivery models and contact tips that facilitate precise targeting and administration. This system is crucial for procedures requiring high precision and control, ensuring effective treatment outcomes.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for procedures involving the portal vein. It is suitable for adult patients requiring targeted therapy for conditions such as portal hypertension or liver tumors. The device's versatility allows it to be used in both hospital and outpatient settings.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in patients needing therapeutic intervention in the portal vein. It is particularly beneficial for conditions that require precise delivery of medication or other therapeutic agents to this area.
Practical Considerations
The device comes in various sizes and configurations to accommodate different procedural needs. It is compatible with standard interventional radiology equipment. Clinicians should be trained in fiber delivery techniques to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the SLT Select Fiber Delivery System used for?
It is used for delivering therapeutic agents into the portal vein during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the portal vein, such as those requiring precise delivery of therapeutic agents.
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.