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asha treatment planning system model asha tps
Intelligent Instruments Pvt.
Summary: The asha treatment planning system by Intelligent Instruments Pvt. is a device used in dialysis access procedures. It is FDA 510k cleared with evidence from 6 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K002132 ↗
Decision Date
October 18, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The asha treatment planning system was cleared by the FDA through the 510k pathway on October 18, 2001. It is manufactured by Intelligent Instruments Pvt. and classified as a Class 2 device.
What It Is
The asha treatment planning system is a device designed to assist in planning dialysis access procedures. It is intended for use by clinicians to optimize treatment strategies for patients requiring dialysis.
Clinical Applications
Commonly used in scenarios involving dialysis access, the asha treatment planning system aids clinicians in planning and executing effective treatment strategies. It is particularly valuable in managing complex cases requiring precise intervention.
Evidence Summary
The available literature includes 6 studies, with a mix of retrospective and prospective designs. These studies span from 2022 to 2024, providing insights into the device's clinical applications and safety.
Reported Outcomes
Published studies report that the asha treatment planning system effectively aids in dialysis access procedures, potentially reducing complications and improving patient outcomes. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include general procedural risks associated with dialysis access devices. The evidence does not specify unique adverse events directly linked to the asha treatment planning system.
Evidence Limitations
The evidence lacks detailed efficacy metrics and specific safety outcomes directly attributable to the device. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for asha treatment planning system?
The device is indicated for use in planning dialysis access procedures, aiding clinicians in optimizing treatment strategies.
What outcomes have been reported in clinical studies?
Studies suggest the device aids in effective dialysis access planning, but specific efficacy outcomes are not detailed.
What complications have been reported?
Reported complications include general procedural risks, with no unique adverse events directly linked to the device.
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.