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a v fistula needle set 354
Sorensen Research
Summary: The a v fistula needle set 354 by Sorensen Research is used for vascular access in hemodialysis. Key evidence highlights its role in predicting access dysfunction and needle-related complications.
FDA Clearance Information
Pathway
510K
Number
K771494 ↗
Decision Date
August 16, 1977
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The a v fistula needle set 354 was cleared by the FDA via the 510(k) pathway on August 16, 1977. It is manufactured by Sorensen Research and classified as a Class 2 device.
What It Is
The a v fistula needle set 354 is a medical device designed for vascular access in hemodialysis patients. It facilitates the connection between the patient's circulatory system and the dialysis machine, allowing for efficient blood filtration.
Clinical Applications
This device is commonly used in patients requiring regular hemodialysis, particularly those with an arteriovenous fistula. It is essential for maintaining vascular access and ensuring effective dialysis treatment.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and prospective cohorts, conducted between 2015 and 2024. These studies explore the device's efficacy in predicting access dysfunction and its associated complications.
Reported Outcomes
Published studies report that the a v fistula needle set 354 is effective in predicting arteriovenous access dysfunction, which is crucial for timely vascular management. Additionally, the device's role in minimizing needle-related complications has been highlighted, although further research is needed to optimize its use.
Safety Profile
Reported complications include needle-related injuries during routine cannulation and inadvertent cannulation injuries. These complications can lead to hemodialysis access issues, necessitating further interventions.
Evidence Limitations
Current evidence is limited by the variability in study designs and the need for larger sample sizes to confirm findings. Further research is needed to explore long-term outcomes and refine the device's application in clinical practice.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set 354?
The device is indicated for vascular access in hemodialysis patients, particularly those with an arteriovenous fistula.
What outcomes have been reported in clinical studies?
Studies have reported the device's efficacy in predicting access dysfunction and reducing needle-related complications.
What complications have been reported?
Safety data indicate needle-related injuries and access complications as potential 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.