đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Planning and management of vascular access for dialysis.
- Use in patients who require dialysis treatment because of renal failure.
Clinical Applications
- Preprocedural planning for creation of hemodialysis vascular access.
- Assessment and planning of vascular access sites in patients receiving or preparing for dialysis.
- Use by clinicians involved in dialysis-access care, including nephrology and vascular surgery teams.
Practical Considerations
- The available FDA summary does not specify device dimensions, physical components, or disposable sizes; consult the current labeling and user manual.
- Compatibility with imaging systems, data formats, and clinical software should be confirmed before use.
- Users should receive training in the planning software and follow institutional protocols for image acquisition, interpretation, and documentation.
- The device supports planning and does not replace clinical assessment, ultrasound, angiography, surgery, medication, or other treatments used to create and maintain dialysis access.
- MRI safety cannot be determined from the available FDA summary; review the manufacturer’s current MRI and equipment-compatibility labeling before use near an MRI system.
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.