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combilines hemodialysis blood tubing set
National Medical Care, Medical Products Div.
Summary: The combilines hemodialysis blood tubing set is used in hemodialysis procedures to facilitate blood flow between the patient and the dialysis machine. Key evidence highlights its role in managing iron loss and immune responses during dialysis.
FDA Clearance Information
Pathway
510K
Number
K962081 ↗
Decision Date
November 1, 1996
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The combilines hemodialysis blood tubing set was cleared by the FDA via the 510(k) pathway on November 1, 1996. It is manufactured by National Medical Care, Medical Products Div., and classified as a Class 2 device.
What It Is
The combilines hemodialysis blood tubing set is a medical device designed to connect a patient's blood circulation with a hemodialysis machine. It facilitates the removal of waste products from the blood in patients with renal failure.
Clinical Applications
This device is commonly used in clinical settings for patients undergoing hemodialysis due to chronic kidney disease or acute kidney injury. It is essential in maintaining efficient blood flow during dialysis sessions.
Evidence Summary
The available literature includes 10 studies, covering a range of study types such as RCTs, prospective, and retrospective analyses. The studies span from 2006 to 2023, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report that the combilines hemodialysis blood tubing set is effective in facilitating dialysis, with considerations for iron loss and immune response. The device's role in managing neutrophil activation and extracellular trap formation has been evaluated.
Safety Profile
Reported complications include hypersensitivity reactions potentially linked to ethylene oxide sterilization, as well as immune responses during dialysis. These findings highlight the need for careful monitoring of patients during use.
Evidence Limitations
The evidence base is limited by the lack of large-scale, long-term studies specifically focused on this device. Further research is needed to fully understand the long-term safety and efficacy of the tubing set in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for combilines hemodialysis blood tubing set?
The device is indicated for use in hemodialysis procedures to facilitate blood flow between the patient and the dialysis machine.
What outcomes have been reported in clinical studies?
Studies have reported on the device's effectiveness in managing iron loss and immune responses during dialysis.
What complications have been reported?
Safety data indicate potential hypersensitivity reactions and immune responses during dialysis sessions.
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.