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focal sim
Computerized Medical Systems
Summary: Focal Sim is a dialysis-access device by Computerized Medical Systems, cleared by the FDA via 510k pathway. It is used primarily in dialysis procedures, with limited evidence available on its clinical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K013112 ↗
Decision Date
December 5, 2001
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Focal Sim was cleared by the FDA through the 510k pathway on December 5, 2001. It is manufactured by Computerized Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
Focal Sim is a medical device designed for use in dialysis procedures. It facilitates access to the vascular system, aiding in the efficient delivery of dialysis treatment. The device is intended for use by clinicians in a clinical setting.
Clinical Applications
Focal Sim is commonly used in scenarios requiring vascular access for dialysis treatment. It is particularly relevant in settings where reliable and efficient access to the bloodstream is critical for patient care.
Evidence Summary
The available literature includes 15 studies, though specific details on study types and outcomes are limited. The studies span a range of years, with some recent publications in 2024.
Reported Outcomes
Published studies report limited specific outcomes related to the efficacy of Focal Sim. The evidence does not provide detailed findings on clinical effectiveness or patient benefits, indicating a need for further research.
Safety Profile
Reported complications include limited safety data, as the available studies do not provide comprehensive information on adverse events or complications associated with Focal Sim.
Evidence Limitations
The evidence base for Focal Sim is limited, with gaps in detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles for this device.
Frequently Asked Questions
What are the clinical indications for Focal Sim?
Focal Sim is indicated for use in dialysis procedures, providing vascular access for efficient treatment delivery.
What outcomes have been reported in clinical studies?
Specific findings on clinical outcomes are limited, with existing studies not providing detailed efficacy data.
What complications have been reported?
Safety data from the evidence is limited, with no comprehensive reports on complications or adverse events.
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.