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odyssey
Permedics
Summary: The Odyssey by Permedics is a Class 2 dialysis-access device cleared by the FDA. It is primarily used for facilitating dialysis access. Current evidence includes 15 studies, but specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K042861 ↗
Decision Date
January 12, 2005
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Odyssey device was cleared by the FDA through the 510(k) pathway on January 12, 2005. It is manufactured by Permedics and classified as a Class 2 device under product code MUJ.
What It Is
The Odyssey is a medical device designed to assist in dialysis access. It is intended for use in patients requiring dialysis, providing a reliable means of vascular access.
Clinical Applications
The Odyssey is commonly used in clinical settings where patients require dialysis, such as in cases of chronic kidney disease. It facilitates efficient and reliable access to the vascular system.
Evidence Summary
The available literature includes 15 studies, primarily narrative and descriptive in nature, with publication dates ranging from 2020 to 2024. The studies do not provide specific data on outcomes or safety.
Reported Outcomes
Published studies report limited specific outcomes related to the Odyssey device. The available literature does not provide detailed efficacy findings directly associated with the device's use in dialysis access.
Safety Profile
Reported complications include limited safety data specific to the Odyssey device. The studies reviewed do not provide detailed information on adverse events or complications directly linked to the device.
Evidence Limitations
The evidence base for the Odyssey device is limited, with a lack of detailed clinical trials or studies providing specific outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Odyssey?
The Odyssey is indicated for use in patients requiring dialysis access.
What outcomes have been reported in clinical studies?
The current evidence does not provide specific outcomes related to the Odyssey device.
What complications have been reported?
The reviewed studies do not provide detailed safety data or reported complications for the Odyssey 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.