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a v fistula needle set 341
Sorensen Research
Summary: The a v fistula needle set 341 by Sorensen Research is used in dialysis access procedures. It is FDA 510k cleared and linked to 15 studies, focusing on outcomes and safety in hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K771493 ↗
Decision Date
August 16, 1977
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The a v fistula needle set 341 was cleared via the FDA 510k pathway on August 16, 1977. Manufactured by Sorensen Research, it is classified as a Class 2 device.
What It Is
The a v fistula needle set 341 is designed for vascular access in hemodialysis patients. It facilitates the connection between the patient’s circulatory system and the dialysis machine, ensuring efficient blood flow during treatment.
Clinical Applications
This device is commonly used in hemodialysis settings for patients requiring long-term vascular access. It is particularly relevant in scenarios involving arteriovenous fistulas or grafts.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and prospective cohorts, with publication years ranging from 2015 to 2024.
Reported Outcomes
Published studies report that the a v fistula needle set 341 is effective in maintaining vascular access patency. The studies highlight its role in reducing needle-related complications and improving the overall success rate of hemodialysis sessions.
Safety Profile
Reported complications include needle-related injuries and venous needle dislodgement. These issues are common in hemodialysis but can be mitigated with proper technique and monitoring.
Evidence Limitations
The evidence base is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and optimize usage protocols.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set 341?
The device is indicated for use in hemodialysis patients requiring vascular access via arteriovenous fistulas or grafts.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access and reduced needle-related complications.
What complications have been reported?
Safety data indicate needle-related injuries and venous needle dislodgement as potential complications.
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.