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hemodialysis blood circuit
Travenol Laboratories
Summary: The hemodialysis blood circuit by Travenol Laboratories is a device used in dialysis to manage blood flow and filtration. Key evidence highlights its role in minimizing clotting and managing anticoagulation during dialysis.
FDA Clearance Information
Pathway
510K
Number
K790591 ↗
Decision Date
May 2, 1979
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The hemodialysis blood circuit was cleared by the FDA through the 510k pathway on May 2, 1979. It is manufactured by Travenol Laboratories and classified as a Class 2 device.
What It Is
The hemodialysis blood circuit is an extracorporeal device designed to facilitate the removal of waste products from the blood in patients with renal failure. It is integral to the hemodialysis process, ensuring efficient blood flow and filtration.
Clinical Applications
This device is commonly used in clinical settings for patients undergoing hemodialysis due to end-stage renal disease. It is essential for maintaining blood circulation outside the body during dialysis sessions.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, published between 2022 and 2025. These studies explore anticoagulation strategies and circuit patency.
Reported Outcomes
Published studies report that the hemodialysis blood circuit effectively manages anticoagulation, with low molecular weight heparin offering predictable dosing. The device is crucial in minimizing clotting and maintaining circuit patency during dialysis.
Safety Profile
Reported complications include bleeding risks associated with anticoagulation, particularly when using unfractionated heparin. Clotting within the circuit remains a challenge, necessitating careful monitoring and management.
Evidence Limitations
Current evidence is limited by a lack of large-scale, multicenter trials. Further research is needed to explore long-term outcomes and optimize anticoagulation protocols in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis blood circuit?
The device is indicated for use in hemodialysis to manage blood flow and filtration in patients with renal failure.
What outcomes have been reported in clinical studies?
Studies report effective anticoagulation management and reduced clotting with the use of low molecular weight heparin.
What complications have been reported?
Safety data indicate bleeding risks and potential clotting within the circuit as primary complications.
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.