📊 Evidence-Based Reference
Art-Plan V 3 0 0
Therapanacea Sas
Summary: art-plan v 3 0 0 is a dialysis-access device by Therapanacea Sas, cleared by the FDA. It is primarily used in dialysis procedures. Current evidence includes five studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K242822 ↗
Decision Date ?
February 25, 2025
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The art-plan v 3 0 0 received FDA clearance through the 510(k) pathway on February 25, 2025. It is manufactured by Therapanacea Sas and classified as a Class 2 device.
What It Is
The art-plan v 3 0 0 is a medical device designed for use in dialysis procedures. It facilitates access to the vascular system, essential for effective dialysis treatment.
FDA-Cleared Indications
- For use in dialysis-related vascular access applications as described by the applicable FDA labeling.
- The supplied FDA record does not provide additional specific anatomical, procedural, or patient-selection indications.
Clinical Applications
- Dialysis vascular-access procedures when the device is used according to its cleared labeling.
- Establishing or maintaining access to the vascular system for patients receiving dialysis.
Evidence Summary
The available literature includes five studies, though specific details on study types, sample sizes, and date ranges are not provided. The studies are registered on ClinicalTrials.gov.
Reported Outcomes
Published studies report limited specific efficacy findings for the art-plan v 3 0 0. The studies listed do not provide detailed outcomes directly related to this device.
Safety Profile
Reported complications include limited safety data as the studies do not specify adverse events directly associated with the art-plan v 3 0 0.
Evidence Limitations
The evidence base for the art-plan v 3 0 0 is limited, with a lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- Confirm the device's exact intended use, dimensions, compatible accessories, and instructions for use before a procedure.
- The supplied record does not identify available sizes, materials, MRI safety status, or compatibility with other dialysis-access equipment.
- Patient selection and use should follow the manufacturer's labeling and the treating team's assessment of the vascular anatomy and dialysis-access plan.
- Potential contraindications, handling requirements, and sterilization or single-use instructions should be verified in the current product labeling.
Frequently Asked Questions
What are the clinical indications for art-plan v 3 0 0?
The device is indicated for use in dialysis procedures, facilitating vascular access.
What outcomes have been reported in clinical studies?
Specific outcomes related to the art-plan v 3 0 0 are not detailed in the available studies.
What complications have been reported?
Safety data specific to the art-plan v 3 0 0 is limited, with no detailed complications reported in the studies.
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.