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a v fistula needle set 364
Sorensen Research
Summary: The a v fistula needle set 364 by Sorensen Research is used in hemodialysis for vascular access. Key evidence highlights its role in reducing needle-related complications.
FDA Clearance Information
Pathway
510K
Number
K771491 ↗
Decision Date
August 16, 1977
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The a v fistula needle set 364 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.
What It Is
The a v fistula needle set 364 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.
Clinical Applications
This device is commonly used in hemodialysis settings to ensure reliable vascular access. It is particularly important for patients with arteriovenous fistulas or grafts.
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 and safety in clinical settings.
Reported Outcomes
Published studies report that the a v fistula needle set 364 is effective in maintaining vascular access patency and reducing needle-related complications. The device is associated with improved outcomes in hemodialysis access management.
Safety Profile
Reported complications include needle-related injuries and venous needle dislodgement. These events are critical considerations in the safe use of the device.
Evidence Limitations
The evidence is limited by the variability in study designs and the need for more large-scale, multicenter trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set 364?
The device is indicated for use in hemodialysis patients requiring vascular access, particularly those with arteriovenous fistulas or grafts.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of vascular access patency and a reduction in needle-related complications.
What complications have been reported?
Safety data indicate complications such as needle-related injuries and venous needle dislodgement.
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.