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Radiance V2
Gmv Soluciones Globales Internet S.A.U.
Summary: Radiance v2 is a dialysis-access device by Gmv Soluciones Globales Internet S.A.U., cleared by the FDA via the 510k pathway. Key evidence includes studies on its application in dialysis access with no specific outcomes or safety data reported.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133655 ↗
Decision Date ?
January 31, 2014
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
Radiance v2 was cleared by the FDA through the 510k pathway on January 31, 2014. It is manufactured by Gmv Soluciones Globales Internet S.A.U. and classified as a Class 2 device under product code MUJ.
What It Is
Radiance v2 is a medical device designed for dialysis access. It facilitates the connection between the patient's vascular system and the dialysis machine, ensuring efficient blood filtration during treatment.
FDA-Cleared Indications
- Use in establishing or maintaining vascular access for hemodialysis, consistent with the FDA product classification for dialysis-access devices.
Clinical Applications
- Supporting vascular access used to connect a patient’s bloodstream with a hemodialysis circuit.
- Use during hemodialysis treatment when repeated access to the bloodstream is required.
- Management of dialysis-related vascular access in patients receiving renal replacement therapy.
Evidence Summary
The available literature includes 7 studies, primarily focusing on the technical aspects of dialysis-access devices. These studies span various years, with no specific outcomes or safety data detailed.
Reported Outcomes
Published studies report no specific efficacy findings related to the Radiance v2 device. The studies primarily focus on technical methodologies without direct clinical outcome data.
Safety Profile
Reported complications include no specific adverse events or safety issues directly associated with the Radiance v2 device, as the studies provided do not focus on safety data.
Evidence Limitations
The evidence lacks specific clinical outcomes and safety data related to the Radiance v2 device. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- The available record does not specify device dimensions, access configuration, flow characteristics, or compatibility with particular dialysis systems; clinicians should consult the current manufacturer labeling.
- Use requires appropriate vascular-access assessment and sterile technique.
- The record does not state MRI safety or conditional-use requirements. MRI compatibility should be confirmed in the device labeling before scanning.
- Potential complications depend on the access procedure and may include bleeding, infection, thrombosis, stenosis, malfunction, or vascular injury.
- Contraindications, dwell time, replacement intervals, and handling requirements should be determined from the current instructions for use.
Frequently Asked Questions
What are the clinical indications for Radiance v2?
Radiance v2 is indicated for use in dialysis access, facilitating vascular access for patients undergoing dialysis treatment.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the provided studies, as they focus on technical aspects rather than clinical efficacy.
What complications have been reported?
No specific complications have been reported in the provided studies, as they do not focus on safety data.
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.