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raycare 3 1
Raysearch Laboratories Ab (Publ)
Summary: RayCare 3 1 is a medical device used in dialysis access procedures, primarily by nephrologists and vascular surgeons. It aids in managing dialysis access for patients with kidney failure.
FDA Clearance Information
Pathway
510K
Number
K200487 ↗
Decision Date
June 10, 2020
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayCare 3 1 was cleared through the FDA 510(k) pathway on June 10, 2020. It is manufactured by Raysearch Laboratories Ab (Publ) and classified as a Class 2 device.
What It Is
RayCare 3 1 is a dialysis-access device designed to assist in the management and maintenance of vascular access for dialysis patients. It is used to ensure reliable and effective access to the bloodstream, which is crucial for patients undergoing hemodialysis. The device is engineered to improve the efficiency and safety of dialysis procedures.
Clinical Applications
RayCare 3 1 is commonly used in nephrology and vascular surgery settings. It is utilized in hospitals and dialysis centers to facilitate vascular access for patients with chronic kidney disease requiring hemodialysis. The device is particularly beneficial for patients with difficult vascular access or those who require frequent dialysis sessions.
Indications for Use
The FDA indications for RayCare 3 1 focus on its use in dialysis access management. It is intended for patients who need reliable vascular access for hemodialysis, including those with chronic kidney disease or end-stage renal disease.
Practical Considerations
Clinicians should consider the compatibility of RayCare 3 1 with existing dialysis equipment and patient-specific anatomical considerations. Proper sizing and technique are essential for optimal device performance and patient safety.
Related Literature
The linked study investigated the performance of prediction models in selecting patients for proton therapy in head and neck cancer. It explored how model evaluation measures like AUC and calibration relate to patient selection outcomes. The study highlighted the importance of accurate model performance for effective patient selection, though it noted limitations in understanding the precise relationship between these measures and clinical outcomes.
Frequently Asked Questions
What is RayCare 3 1 used for?
RayCare 3 1 is used for managing dialysis access in patients requiring hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use RayCare 3 1.
What are the FDA-cleared indications?
RayCare 3 1 is indicated for use in dialysis access management for patients needing hemodialysis.
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.