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rayautoplan 1 0
Raysearch Laboratories Ab
Summary: Rayautoplan 1 0 is a dialysis-access device developed by Raysearch Laboratories Ab. It is primarily used in dialysis procedures. Key evidence includes FDA clearance and multiple peer-reviewed studies.
FDA Clearance Information
Pathway 510K
Number K083264 ↗
Decision Date January 22, 2009
Product Code MUJ
Device Class Class 2
Evidence 0 studies
Rayautoplan 1 0 was cleared by the FDA through the 510(k) pathway on January 22, 2009. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device under product code MUJ.
What It Is
Rayautoplan 1 0 is a medical device designed for use in dialysis procedures. It facilitates access to the vascular system, which is crucial for effective dialysis treatment.
Clinical Applications
This device is commonly used in clinical settings for patients requiring dialysis, particularly those with chronic kidney disease. It aids in establishing reliable vascular access.
Evidence Summary
The available literature includes 10 peer-reviewed studies, encompassing various study types such as RCTs, prospective, and retrospective studies. The studies span from 2021 to 2024.
Reported Outcomes
Published studies report varied outcomes related to the efficacy of dialysis-access devices. However, specific outcomes related to rayautoplan 1 0 are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with dialysis-access devices, though specific safety data for rayautoplan 1 0 is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific outcomes and safety data for rayautoplan 1 0, indicating a need for more targeted research. Further studies could provide more detailed insights into its clinical efficacy and safety profile.
Frequently Asked Questions
What are the clinical indications for rayautoplan 1 0?
Rayautoplan 1 0 is indicated for use in dialysis procedures, particularly for establishing vascular access in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Specific outcomes for rayautoplan 1 0 are not detailed in the provided evidence. General outcomes for dialysis-access devices include improved vascular access for dialysis.
What complications have been reported?
Safety data specific to rayautoplan 1 0 is not detailed in the provided evidence. General complications for dialysis-access devices may include infection and thrombosis.
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.