đź“Š Evidence-Based Reference
blood tubing lines for hemodialysis av06c-e
Nikkiso
Summary: Blood tubing lines for hemodialysis AV06C-E by Nikkiso are used in hemodialysis to facilitate blood circulation. Key evidence highlights their role in preventing coagulation and ensuring biocompatibility.
FDA Clearance Information
Pathway
510K
Number
K231589 ↗
Decision Date
July 28, 2023
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The blood tubing lines for hemodialysis AV06C-E by Nikkiso received FDA clearance through the 510(k) pathway on July 28, 2023. It is classified as a Class 2 device.
What It Is
The blood tubing lines for hemodialysis AV06C-E are medical-grade polymeric tubes used in hemodialysis to transport blood between the patient and the dialysis machine. They are designed to ensure safe and effective blood circulation during treatment.
Clinical Applications
These tubing lines are commonly used in clinical settings for patients undergoing hemodialysis, particularly in managing chronic kidney disease. They are integral to the extracorporeal circuit, facilitating the removal of waste products from the blood.
Evidence Summary
The literature includes 15 studies, ranging from 2006 to 2024, encompassing various study types such as RCTs and case series. These studies focus on the device's efficacy in preventing coagulation and its biocompatibility.
Reported Outcomes
Published studies report that the blood tubing lines effectively prevent coagulation during hemodialysis, with evidence supporting their biocompatibility and safety. The use of sensors for therapy customization has also been explored, enhancing treatment outcomes.
Safety Profile
Reported complications include the potential for white thrombus formation and leakage currents during dialysis, particularly when using central dialysis catheters. These issues highlight the importance of monitoring and device maintenance.
Evidence Limitations
The evidence is limited by the small number of studies focusing on long-term outcomes and the need for more comprehensive safety data. Further research is needed to explore the impact of different materials and designs on device performance.
Frequently Asked Questions
What are the clinical indications for blood tubing lines for hemodialysis?
Blood tubing lines are indicated for use in hemodialysis to facilitate blood circulation between the patient and the dialysis machine, particularly in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of coagulation and good biocompatibility, with some exploration of sensor integration for therapy customization.
What complications have been reported?
Safety data indicate potential complications such as white thrombus formation and leakage currents, especially with central dialysis catheters.
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.