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raycare 2 3
Raysearch Laboratories Ab (Publ)
Summary: RayCare 2 3 is a medical device used in dialysis access procedures, manufactured by Raysearch Laboratories. It is typically used by nephrologists and vascular surgeons to facilitate dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K191384 ↗
Decision Date
July 8, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RayCare 2 3 was cleared through the FDA 510(k) pathway on July 8, 2019. It is manufactured by Raysearch Laboratories Ab and classified as a Class 2 device under product code MUJ.
What It Is
RayCare 2 3 is a medical device designed to assist in dialysis access procedures. It is part of a suite of tools used to create and maintain vascular access for patients undergoing dialysis. The device integrates with existing dialysis systems to improve the efficiency and safety of access procedures, ensuring reliable vascular access for effective dialysis treatment.
Clinical Applications
RayCare 2 3 is commonly used in clinical settings where dialysis is performed, such as hospitals and specialized dialysis centers. Nephrologists and vascular surgeons use this device to create and maintain access points in patients requiring long-term dialysis. It is particularly valuable in managing patients with chronic kidney disease who need regular dialysis sessions.
Indications for Use
The FDA has cleared RayCare 2 3 for use in dialysis access procedures. This means it is intended for patients who require vascular access for dialysis, typically those with chronic kidney disease or end-stage renal disease.
Practical Considerations
RayCare 2 3 is compatible with standard dialysis equipment and is available in various sizes to accommodate different patient anatomies. Clinicians should be familiar with the device's integration into existing dialysis systems and ensure proper technique to optimize patient outcomes.
Frequently Asked Questions
What is RayCare 2 3 used for?
RayCare 2 3 is used for creating and maintaining vascular access in patients undergoing dialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use RayCare 2 3 in dialysis procedures.
What are the FDA-cleared indications?
RayCare 2 3 is cleared for use in dialysis access procedures for patients needing vascular access for dialysis.
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.