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hemodialysis venous arterial set
Amisco Trading
Summary: The hemodialysis venous arterial set by Amisco Trading is used in dialysis procedures to facilitate blood flow. Key evidence highlights its role in maintaining vascular access and potential complications related to hemodynamic changes.
FDA Clearance Information
Pathway
510K
Number
K812622 ↗
Decision Date
September 24, 1981
Product Code
FKH
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 24, 1981. It is manufactured by Amisco Trading and classified as a Class 2 device under product code FKH.
What It Is
The hemodialysis venous arterial set is a medical device used to connect the patient's vascular system to the dialysis machine, allowing for efficient blood flow during hemodialysis. It is intended for use in patients requiring renal replacement therapy.
Clinical Applications
Commonly used in clinical settings for patients undergoing maintenance hemodialysis, the device is crucial for ensuring effective blood filtration and removal of waste products. It is typically employed in both hospital and outpatient dialysis centers.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, retrospective, and prospective studies, conducted between 2016 and 2025. These studies explore the device's impact on hemodynamic parameters and vascular access maintenance.
Reported Outcomes
Published studies report that the hemodialysis venous arterial set is effective in maintaining vascular access and facilitating efficient dialysis. However, changes in hemodynamic parameters, such as shear stress, have been observed, which may affect vascular health.
Safety Profile
Reported complications include catheter-related infections and hemodynamic changes that may impact vascular access longevity. These issues highlight the importance of monitoring and managing vascular access during hemodialysis.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, long-term studies. Further research is needed to explore the long-term effects of hemodynamic changes and to develop strategies for minimizing complications.
Frequently Asked Questions
What are the clinical indications for hemodialysis venous arterial set?
The device is indicated for use in patients requiring hemodialysis to facilitate blood flow between the patient and the dialysis machine.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of vascular access and efficient dialysis, with some concerns about hemodynamic changes affecting vascular health.
What complications have been reported?
Safety data indicate complications such as catheter-related infections and hemodynamic changes that may compromise vascular access.
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.