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art-plan v3 1 0
Therapanacea Sas
Summary: The art-plan v3 1 0 is a medical device used for dialysis access. It is primarily used by nephrologists and vascular surgeons to facilitate dialysis treatment in patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K253091 ↗
Decision Date
December 23, 2025
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The art-plan v3 1 0 by Therapanacea Sas was cleared through the FDA 510k pathway on December 23, 2025. It is classified as a Class 2 device under product code MUJ.
What It Is
The art-plan v3 1 0 is a specialized medical device designed to assist in the creation and maintenance of vascular access for dialysis. It aids in planning and optimizing the placement of dialysis access points, ensuring efficient and effective treatment. The device uses advanced imaging and planning algorithms to improve outcomes for patients requiring long-term dialysis.
Clinical Applications
This device is commonly used in nephrology and vascular surgery settings, particularly in hospitals and specialized dialysis centers. It is essential for patients with chronic kidney disease who require regular dialysis treatments. The art-plan v3 1 0 helps clinicians plan and execute procedures to establish reliable vascular access, which is crucial for effective dialysis.
Indications for Use
The FDA indications suggest that this device is intended for use in patients needing dialysis access, typically those with end-stage renal disease. It assists in the planning and management of vascular access sites.
Practical Considerations
Clinicians should be aware of the device's compatibility with various imaging systems and its integration into existing dialysis protocols. Proper training on the device's software and planning tools is recommended to maximize its utility.
Related Literature
The linked study, titled 'Photovoice for Spinal Cord Injury to Prevent Falls,' does not directly relate to the art-plan v3 1 0. It appears to focus on using photovoice methodology to address fall prevention in spinal cord injury patients. However, details such as the year and abstract are unavailable, limiting further insights.
Frequently Asked Questions
What is art-plan v3 1 0 used for?
The device is used for planning and optimizing dialysis access in patients with renal failure.
What specialties typically use this device?
Nephrologists and vascular surgeons commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in planning and managing vascular access for dialysis in patients with kidney disease.
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.