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acute dual lumen hemodialysis catheter
Health Line International
Summary: The acute dual lumen hemodialysis catheter by Health Line International is used for temporary vascular access in dialysis. Key evidence highlights design features impacting infection risks.
FDA Clearance Information
Pathway 510K
Number K200426 ↗
Decision Date December 24, 2020
Product Code MPB
Device Class Class 2
Evidence 0 studies
The device was cleared through the FDA 510(k) pathway on December 24, 2020, by Health Line International. It is classified as a Class 2 device under product code MPB.
What It Is
The acute dual lumen hemodialysis catheter is a non-tunneled device designed for short-term vascular access in patients requiring hemodialysis. It facilitates efficient blood flow for dialysis procedures.
Clinical Applications
Commonly used in acute settings for patients with acute kidney injury (AKI) requiring urgent renal replacement therapy. It is typically inserted into the right internal jugular vein for optimal access.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 2022 and 2025. These studies evaluate design features, usage trends, and associated risks.
Reported Outcomes
Published studies report that the design features of dual lumen catheters, such as lumen number and material, can influence infection rates. The use of real-time ultrasound during insertion reduces mechanical complications.
Safety Profile
Reported complications include infection and mechanical issues related to catheter insertion. The use of ultrasound guidance has been shown to mitigate some of these risks.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically comparing dual lumen catheters to other designs. Further research is needed to explore long-term outcomes and safety.
Frequently Asked Questions
What are the clinical indications for acute dual lumen hemodialysis catheter?
The catheter is indicated for temporary vascular access in patients requiring hemodialysis, particularly in cases of acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report that catheter design features can impact infection rates and that ultrasound guidance reduces mechanical complications.
What complications have been reported?
Safety data indicate risks of infection and mechanical complications, though ultrasound guidance can reduce these issues.
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.