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vitesse 2 0
Varian Medical Systems
Summary: Vitesse 2 0 is a dialysis-access device by Varian Medical Systems, primarily used in dialysis procedures. Key evidence includes studies on mechanical and biochemical factors affecting device performance.
FDA Clearance Information
Pathway
510K
Number
K051497 ↗
Decision Date
July 18, 2005
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Vitesse 2 0 was cleared through the FDA 510(k) pathway on July 18, 2005. It is manufactured by Varian Medical Systems and classified as a Class 2 device.
What It Is
The Vitesse 2 0 is a medical device designed for dialysis access. It facilitates efficient and reliable vascular access for patients undergoing dialysis, ensuring optimal treatment delivery.
Clinical Applications
Commonly used in dialysis centers, the Vitesse 2 0 is employed in scenarios requiring repeated vascular access, such as chronic kidney disease management. It supports effective dialysis treatment by maintaining stable access.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and prospective analyses. These studies span from 2018 to 2019, providing insights into device performance and clinical outcomes.
Reported Outcomes
Published studies report on the mechanical and biochemical determinants of device performance, with specific outcomes related to muscle fiber conduction velocity and bone development. However, direct efficacy findings specific to the Vitesse 2 0 are limited.
Safety Profile
Reported complications include mechanical issues related to device placement and maintenance. However, specific adverse events directly associated with the Vitesse 2 0 are not detailed in the provided evidence.
Evidence Limitations
The evidence base lacks direct studies on the Vitesse 2 0, with most research focusing on related physiological parameters. Further research is needed to establish direct efficacy and safety outcomes for this device.
Frequently Asked Questions
What are the clinical indications for Vitesse 2 0?
The Vitesse 2 0 is indicated for use in dialysis access, facilitating vascular access for patients undergoing dialysis treatment.
What outcomes have been reported in clinical studies?
Studies have reported on factors like muscle fiber conduction velocity and bone development, but direct outcomes specific to the Vitesse 2 0 are not detailed.
What complications have been reported?
Reported complications include mechanical issues related to device placement, but specific adverse events for the Vitesse 2 0 are not detailed in the evidence.
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.