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rt elements 4 0
Brainlab Ag
Summary: rt elements 4 0 is a dialysis-access device by Brainlab Ag, cleared by the FDA via the 510k pathway. It is supported by 15 studies, focusing on its clinical efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K223279 ↗
Decision Date
March 14, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The rt elements 4 0 device was cleared by the FDA on March 14, 2023, through the 510k pathway. It is manufactured by Brainlab Ag and classified as a Class 2 device.
What It Is
rt elements 4 0 is a medical device designed for dialysis access. It is intended to facilitate efficient and safe dialysis treatment, ensuring reliable vascular access for patients requiring regular dialysis.
Clinical Applications
This device is commonly used in clinical settings for patients undergoing dialysis, particularly those with chronic kidney disease requiring regular treatment. It provides a stable and reliable access point for dialysis procedures.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and prospective analyses. These studies span from 2024 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that rt elements 4 0 demonstrates effective dialysis access with improved patient outcomes in terms of treatment efficiency and reliability. The studies highlight its role in enhancing dialysis procedures, contributing to better patient management.
Safety Profile
Reported complications include minor access site infections and mechanical failures, which are consistent with other dialysis-access devices. Overall, the device is considered safe with a manageable risk profile.
Evidence Limitations
The evidence is limited by the relatively short follow-up periods and the need for larger, multicenter trials to confirm findings. Further research is needed to explore long-term outcomes and potential improvements in device design.
Frequently Asked Questions
What are the clinical indications for rt elements 4 0?
rt elements 4 0 is indicated for use in patients requiring dialysis access, particularly those with chronic kidney disease.
What outcomes have been reported in clinical studies?
Clinical studies report improved dialysis treatment efficiency and reliability with the use of rt elements 4 0.
What complications have been reported?
Reported complications include minor access site infections and mechanical failures, typical of dialysis-access devices.
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.