đź“Š Evidence-Based Reference
arterial blood tubing set for single needle hemodialysis
Baxter Healthcare
Summary: The arterial blood tubing set for single needle hemodialysis by Baxter Healthcare is designed for use in hemodialysis procedures. It is FDA 510k cleared and supported by 13 studies, focusing on its application in dialysis-access devices.
FDA Clearance Information
Pathway
510K
Number
K955277 ↗
Decision Date
February 16, 1996
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on February 16, 1996. It is manufactured by Baxter Healthcare and classified as a Class 2 device under product code KOC.
What It Is
The arterial blood tubing set for single needle hemodialysis is a medical device used to facilitate the removal and return of blood during hemodialysis. It is designed to optimize blood flow and minimize complications associated with dialysis procedures.
Clinical Applications
This device is commonly used in clinical settings for patients undergoing hemodialysis, particularly in scenarios where single needle access is preferred. It is integral to dialysis-access devices, ensuring efficient blood circulation during treatment.
Evidence Summary
The literature includes 13 studies, spanning from 2016 to 2023, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies provide insights into the device's performance and safety.
Reported Outcomes
Published studies report that the arterial blood tubing set effectively supports hemodialysis by maintaining adequate blood flow and minimizing pressure drops. The device's design has been evaluated in different clinical scenarios, showing consistent performance in dialysis settings.
Safety Profile
Reported complications include potential clotting within the tubing, particularly in hypercoagulable conditions. However, studies have validated setups that mitigate these risks, ensuring safe and prolonged use during dialysis.
Evidence Limitations
The evidence is limited by the variability in study designs and the specific focus on pediatric and preclinical models. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for arterial blood tubing set for single needle hemodialysis?
The device is indicated for use in hemodialysis procedures, particularly where single needle access is required to facilitate blood removal and return.
What outcomes have been reported in clinical studies?
Studies have reported effective blood flow maintenance and minimized pressure drops during hemodialysis, with consistent performance across different clinical scenarios.
What complications have been reported?
Safety data indicate potential clotting issues, especially in hypercoagulable conditions, but validated setups have been shown to reduce these risks.
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.