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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 ?
510(k)
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.
FDA-Cleared Indications
- Use in establishing vascular access for dialysis.
- Use in maintaining vascular access for dialysis.
Clinical Applications
- Establishing vascular access for patients who require dialysis.
- Maintaining existing vascular access during ongoing dialysis care.
Practical Considerations
- Confirm the device configuration, dimensions and sizing requirements in the current manufacturer’s instructions for use before use.
- Verify compatibility with the planned dialysis access equipment and other procedural components.
- Use appropriate imaging guidance and sterile technique according to the access procedure and institutional protocol.
- Review the manufacturer’s MRI safety labeling; MRI safety cannot be determined from the FDA product code alone.
- Assess the patient’s vascular anatomy, access site and contraindications before the procedure.
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.