📊 Evidence-Based Reference
A V Fistula Needle Set 361
Sorensen Research
Summary: The a v fistula needle set 361 by Sorensen Research is a device used in dialysis access. It is FDA 510k cleared and primarily used for hemodialysis. Key evidence highlights its role in maintaining vascular access patency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K771495 ↗
Decision Date ?
August 16, 1977
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The a v fistula needle set 361 was cleared through 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 361 is designed for use in hemodialysis, facilitating access to the vascular system via an arteriovenous fistula. It is intended to provide reliable and efficient vascular access for dialysis patients.
FDA-Cleared Indications
- Access to an established arteriovenous fistula for hemodialysis.
- Use as a fistula needle set to provide vascular access during dialysis treatment.
Clinical Applications
- Needle access to an arteriovenous fistula before hemodialysis.
- Withdrawal of blood from the fistula for extracorporeal dialysis.
- Return of dialyzed blood to the fistula during hemodialysis.
- Use in patients with a mature surgical arteriovenous fistula used for dialysis access.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and prospective cohorts, spanning from 2015 to 2024. These studies focus on the efficacy and safety of dialysis access devices.
Reported Outcomes
Published studies report that the a v fistula needle set 361 is effective in maintaining vascular access patency during hemodialysis. It has been associated with reduced incidence of access dysfunction and improved patient outcomes in terms of dialysis efficiency.
Safety Profile
Reported complications include needle-related injuries and venous needle dislodgement, which can lead to significant clinical issues. However, the device is generally considered safe when used according to established protocols.
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 explore long-term outcomes and optimize usage protocols.
Practical Considerations
- The set is intended for an established arteriovenous fistula; it is not a substitute for creating or repairing dialysis access.
- Needle gauge, length, and configuration should match the fistula anatomy, prescribed blood-flow rate, and dialysis equipment.
- Use requires trained dialysis personnel and sterile handling to reduce bleeding, infiltration, infection, and loss of access function.
- The record does not provide sufficient information to determine MRI safety; consult the current manufacturer labeling before MRI.
- Do not use through an infected, thrombosed, immature, or otherwise unsuitable access unless directed by the treating clinician.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set 361?
The device is indicated for use in hemodialysis patients requiring vascular access via an arteriovenous fistula.
What outcomes have been reported in clinical studies?
Studies have shown effective maintenance of vascular access patency and reduced access dysfunction.
What complications have been reported?
Complications include needle-related injuries and venous needle dislodgement, though these are generally manageable with proper technique.
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.