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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 ?
510(k)
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.
FDA-Cleared Indications
- Intended for use in vascular access procedures related to hemodialysis.
- Intended to help establish or maintain access to the bloodstream for patients requiring repeated dialysis treatments.
Clinical Applications
- Use during procedures to establish dialysis vascular access.
- Use in the management or maintenance of access associated with arteriovenous fistulas.
- Use in the management or maintenance of access associated with arteriovenous grafts.
- Use in hospital or dialysis-center settings for patients requiring recurring hemodialysis access.
Practical Considerations
- The supplied record does not identify the device configuration, dimensions, or available sizes; clinicians should verify these details in the current instructions for use.
- Confirm compatibility with the intended dialysis access equipment and any connected components before use.
- Use appropriate sterile technique and imaging or procedural guidance as specified by the labeling and institutional protocol.
- Review the complete labeling for contraindications, warnings, handling instructions, and maintenance requirements.
- MRI safety or conditional status is not established in the supplied record; verify the manufacturer’s current MRI labeling before scanning.
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.