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ergo version 1 7
3D Line Medical Systems S.R.L.
Summary: The ergo version 1 7 is a dialysis-access device designed for clinical use in managing dialysis procedures. It is FDA 510(k) cleared and supported by five studies, although specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K080601 ↗
Decision Date
June 6, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The ergo version 1 7 was cleared by the FDA through the 510(k) pathway on June 6, 2008. It is manufactured by 3D Line Medical Systems S.R.L. and classified as a Class 2 device under product code MUJ.
What It Is
The ergo version 1 7 is a medical device used in dialysis access procedures. It facilitates the connection and management of dialysis treatments, ensuring efficient and safe blood filtration for patients with renal failure.
Clinical Applications
This device is commonly used in clinical settings for patients requiring dialysis, particularly those with chronic kidney disease. It is essential for establishing and maintaining vascular access during dialysis sessions.
Evidence Summary
The available literature includes five studies, primarily registered on clinical trial databases. These studies vary in type, including randomized controlled trials and observational studies, but specific details on outcomes and safety are sparse.
Reported Outcomes
Published studies report limited specific outcomes related to the efficacy of the ergo version 1 7. The studies focus on broader topics such as physical activity and rehabilitation, with no direct findings on dialysis access efficacy.
Safety Profile
Reported complications include general safety concerns typical of dialysis-access devices, but specific adverse events related to the ergo version 1 7 are not detailed in the provided evidence.
Evidence Limitations
The evidence base for the ergo version 1 7 is limited, with a lack of detailed outcome and safety data specific to the device. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for ergo version 1 7?
The device is indicated for use in dialysis access procedures, facilitating vascular access for patients undergoing dialysis.
What outcomes have been reported in clinical studies?
Specific outcomes related to the device are not detailed in the available studies, which focus on broader health topics.
What complications have been reported?
Safety data specific to the ergo version 1 7 is limited, with general complications typical of dialysis-access devices mentioned.
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.