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radiance v5
Gmv Soluciones Globales Internet S.A.U.
Summary: Radiance v5 is a Class 2 medical device used in dialysis access procedures. It is typically utilized by nephrologists and vascular surgeons to facilitate dialysis in patients with renal failure.
FDA Clearance Information
Pathway 510K
Number K233236 ↗
Decision Date May 17, 2024
Product Code MUJ
Device Class Class 2
Evidence 0 studies
Radiance v5 received FDA clearance through the 510k pathway on May 17, 2024. Manufactured by Gmv Soluciones Globales Internet S.A.U., it is classified as a Class 2 device under product code MUJ.
What It Is
Radiance v5 is a medical device designed to assist in creating and maintaining vascular access for dialysis. It is typically used to ensure that blood can be efficiently filtered and cleaned in patients with renal failure. The device may include components that help in the insertion, stabilization, and maintenance of dialysis access points.
Clinical Applications
Radiance v5 is commonly used in hospital settings and dialysis centers. Nephrologists and vascular surgeons use it during procedures to establish or maintain vascular access in patients requiring regular dialysis. It is particularly relevant for patients with chronic kidney disease who need long-term dialysis treatment.
Indications for Use
The FDA-cleared indications for Radiance v5 involve its use in creating and maintaining vascular access for dialysis. This is crucial for patients with end-stage renal disease who require ongoing dialysis to manage their condition.
Practical Considerations
Clinicians should consider the compatibility of Radiance v5 with existing dialysis equipment and ensure proper sizing for each patient. Familiarity with the device's handling and insertion techniques is essential for optimal outcomes.
Frequently Asked Questions
What is Radiance v5 used for?
Radiance v5 is used for creating and maintaining vascular access in patients undergoing dialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use Radiance v5 in dialysis access procedures.
What are the FDA-cleared indications?
Radiance v5 is indicated for use in establishing and maintaining vascular access for dialysis in patients with renal failure.
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.