đź“Š Evidence-Based Reference
a v fistula needle set 344
Sorensen Research
Summary: The a v fistula needle set 344 is a device used in hemodialysis for vascular access. It is primarily used to facilitate the connection between the patient and the dialysis machine. Key evidence highlights the importance of early detection of access dysfunction.
FDA Clearance Information
Pathway
510K
Number
K771490 ↗
Decision Date
August 16, 1977
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The a v fistula needle set 344 was cleared by the FDA through the 510(k) pathway on August 16, 1977. It is manufactured by Sorensen Research and classified as a Class 2 device under product code FIE.
What It Is
The a v fistula needle set 344 is designed for use in hemodialysis to provide vascular access through an arteriovenous fistula. It facilitates the transfer of blood between the patient and the dialysis machine, ensuring effective treatment.
Clinical Applications
This device is commonly used in patients undergoing hemodialysis who have an established arteriovenous fistula. It is essential for routine dialysis sessions, allowing for efficient blood flow and treatment delivery.
Evidence Summary
The available literature includes 15 studies, ranging from 2015 to 2024, encompassing various study types such as RCTs and prospective cohorts. These studies focus on the prediction of access dysfunction and needle-related complications.
Reported Outcomes
Published studies report that early detection of arteriovenous access dysfunction can significantly improve patient outcomes by preventing complications. The use of deep learning models has shown promise in predicting access malfunctions. Additionally, the incidence of needle-related complications remains a concern, highlighting the need for improved cannulation techniques.
Safety Profile
Reported complications include needle-related injuries during routine cannulation, which can lead to access dysfunction. Venous needle dislodgement is another significant risk, potentially resulting in severe complications if not promptly detected.
Evidence Limitations
Current evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish standardized protocols for needle use and to explore advanced detection methods for access dysfunction.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set 344?
The device is indicated for use in hemodialysis patients with an arteriovenous fistula to facilitate vascular access.
What outcomes have been reported in clinical studies?
Studies have reported improved detection of access dysfunction and highlighted the need for better cannulation techniques to reduce complications.
What complications have been reported?
Safety data indicate needle-related injuries and venous needle dislodgement as common complications associated with the 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.