Rayautoplan 1 0
Raysearch Laboratories Ab
FDA Clearance Information
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
FDA-Cleared Indications
- Used to facilitate vascular access for dialysis procedures.
Clinical Applications
- Establishing access to the vascular system for dialysis.
- Supporting vascular access procedures in patients receiving dialysis.
- Use in clinical dialysis settings when reliable vascular access is required.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The available FDA summary does not provide detailed information about device dimensions, configuration, materials, or accessory compatibility.
- Use should follow the manufacturer’s instructions for preparation, placement, handling, and connection to dialysis equipment.
- The record does not specify MRI safety labeling; MRI use should be determined from the current manufacturer labeling.
- Patient-specific risks include bleeding, infection, thrombosis, vascular injury, and loss of access.
- The device should not be used outside its cleared dialysis-access indication unless an appropriately qualified clinician determines that off-label use is justified.
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.