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jms sysloc a v fistula needle set jms sysloc apheresis needle set
Jms North America
Summary: The JMS Sysloc A V Fistula Needle Set is used for vascular access in hemodialysis. It is FDA 510k cleared and linked to studies on AV fistula patency and blood trauma. Key evidence highlights the need for improved AVF maturation.
FDA Clearance Information
Pathway
510K
Number
K030479 ↗
Decision Date
August 18, 2003
Product Code
FOZ
Device Class
Class 2
Evidence
0 studies
The JMS Sysloc A V Fistula Needle Set was cleared by the FDA via the 510k pathway on August 18, 2003. It is manufactured by Jms North America and classified as a Class 2 device.
What It Is
The JMS Sysloc A V Fistula Needle Set is designed for vascular access in hemodialysis patients. It facilitates reliable blood flow during dialysis sessions, essential for effective treatment.
Clinical Applications
Commonly used in patients requiring hemodialysis, the device is integral in establishing and maintaining vascular access, particularly in those with arteriovenous fistulas.
Evidence Summary
The available literature includes two studies, one from 2002 and another from 2020, focusing on AV fistula patency and blood trauma. These studies encompass various methodologies, including RCTs and in vitro evaluations.
Reported Outcomes
Published studies report that stimulation of Caveolin-1 signaling may improve AV fistula patency, addressing common issues with AVF maturation. Another study evaluates hemolysis and blood trauma in vascular access systems, highlighting the need for reliable blood flow.
Safety Profile
Reported complications include potential blood trauma and thrombosis associated with vascular access systems. These findings underscore the importance of monitoring for adverse events during hemodialysis.
Evidence Limitations
The evidence is limited by the small number of studies and the need for more comprehensive research on long-term outcomes and safety. Further studies are required to validate findings and explore new interventions for AVF maturation.
Frequently Asked Questions
What are the clinical indications for JMS Sysloc A V Fistula Needle Set?
The device is indicated for use in establishing vascular access for hemodialysis, particularly in patients with arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies have reported improved AV fistula patency and evaluated hemolysis and blood trauma in vascular access systems.
What complications have been reported?
Safety data indicate potential complications such as blood trauma and thrombosis associated with vascular access systems.
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.