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radiance v3
Gmv Soluciones Globales Internet S.A.U.
Summary: The Radiance v3 is a medical device used for dialysis access procedures, primarily by nephrologists and vascular surgeons. It facilitates efficient vascular access for patients undergoing dialysis.
FDA Clearance Information
Pathway
510K
Number
K153368 ↗
Decision Date
February 16, 2016
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Radiance v3 by Gmv Soluciones Globales Internet S.A.U. received FDA clearance via the 510(k) pathway on February 16, 2016. It is classified as a Class 2 device under product code MUJ.
What It Is
The Radiance v3 is a specialized medical device designed to assist in the creation and maintenance of vascular access for dialysis patients. It is engineered to improve the efficiency and safety of accessing blood vessels, which is crucial for effective dialysis treatment. The device incorporates advanced materials and design features to ensure compatibility with existing dialysis systems.
Clinical Applications
The Radiance v3 is commonly used in nephrology and vascular surgery settings, particularly in hospitals and dialysis centers. It is employed during procedures to establish or maintain arteriovenous fistulas or grafts, which are essential for patients requiring regular dialysis. The device is particularly beneficial for patients with chronic kidney disease who need reliable and repeated vascular access.
Indications for Use
The FDA indications for the Radiance v3 focus on its use in creating and maintaining vascular access for dialysis. This means it is intended for patients who require regular dialysis treatments and need a reliable method to access their bloodstream.
Practical Considerations
Clinicians should be aware of the device's compatibility with standard dialysis equipment and its availability in various sizes to accommodate different patient anatomies. Proper technique during insertion and maintenance is crucial to minimize complications and ensure long-term functionality.
Frequently Asked Questions
What is Radiance v3 used for?
The Radiance v3 is used to create and maintain vascular access for patients undergoing dialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is cleared for use in establishing and maintaining vascular access for dialysis patients.
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.