đź“Š Evidence-Based Reference
art-plan v 2 2 0
Therapanacea Sas
Summary: art-plan v 2 2 0 is a clinician-facing device by Therapanacea Sas, primarily used in dialysis-access-devices. Key evidence findings are not specified in the linked studies.
FDA Clearance Information
Pathway
510K
Number
K234068 ↗
Decision Date
April 22, 2024
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The art-plan v 2 2 0 received FDA clearance through the 510(k) pathway on April 22, 2024. It is manufactured by Therapanacea Sas and classified as a Class 2 device under product code MUJ.
What It Is
art-plan v 2 2 0 is a medical device designed for use in dialysis-access-devices. It is intended to assist clinicians in planning and managing dialysis access, improving procedural outcomes.
Clinical Applications
This device is commonly used in clinical scenarios involving dialysis access, such as planning and optimizing vascular access for dialysis patients. It provides practical support in ensuring effective and safe dialysis procedures.
Evidence Summary
The available literature includes 5 studies, though specific details on study types, participant numbers, and date ranges are not provided. The studies are linked but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report no specific efficacy findings related to art-plan v 2 2 0, as the linked studies do not provide detailed outcomes relevant to this device.
Safety Profile
Reported complications include no specific adverse events or safety data, as the linked studies do not provide relevant safety information for art-plan v 2 2 0.
Evidence Limitations
The evidence base for art-plan v 2 2 0 is limited by the lack of detailed study outcomes and safety data. Further research is needed to establish specific efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for art-plan v 2 2 0?
art-plan v 2 2 0 is indicated for use in dialysis-access-devices, assisting in planning and managing dialysis access.
What outcomes have been reported in clinical studies?
Specific findings from the linked evidence are not available for art-plan v 2 2 0.
What complications have been reported?
Safety data from the linked evidence do not provide specific information on complications for art-plan v 2 2 0.
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.