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amecath dual lumen hemodialysis catheter
Ameco Medical Industries
Summary: The Amecath dual lumen hemodialysis catheter is designed for temporary vascular access in hemodialysis. Key evidence highlights its use in managing acute kidney injury with associated risks of infection and mechanical complications.
FDA Clearance Information
Pathway
510K
Number
K123943 ↗
Decision Date
April 2, 2013
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Amecath dual lumen hemodialysis catheter was cleared by the FDA via the 510(k) pathway on April 2, 2013. Manufactured by Ameco Medical Industries, it is classified as a Class 2 device.
What It Is
The Amecath dual lumen hemodialysis catheter is a non-tunneled device used for short-term hemodialysis access. It facilitates efficient blood flow for dialysis in patients with acute kidney injury or other conditions requiring temporary vascular access.
Clinical Applications
Commonly used in acute settings, this catheter provides temporary vascular access for hemodialysis in patients with acute kidney injury. It is often employed in ICU settings where rapid initiation of dialysis is necessary.
Evidence Summary
The literature includes 10 studies, comprising retrospective evaluations and reviews, published between 2022 and 2025. These studies focus on design features, infection risks, and procedural outcomes associated with dual lumen catheters.
Reported Outcomes
Published studies report that dual lumen catheters are effective for temporary hemodialysis access, with design features impacting infection rates. The catheter's efficacy in maintaining adequate blood flow for dialysis is well-documented, although site-specific infection risks vary.
Safety Profile
Reported complications include catheter-related bloodstream infections, particularly when placed in the femoral site. Mechanical complications such as occlusion and thrombosis are also noted, emphasizing the need for careful site selection and monitoring.
Evidence Limitations
Current evidence is limited by retrospective study designs and a focus on short-term outcomes. Further research is needed to evaluate long-term safety and efficacy, as well as to compare outcomes across different catheter designs and insertion sites.
Frequently Asked Questions
What are the clinical indications for Amecath dual lumen hemodialysis catheter?
The catheter is indicated for temporary vascular access in patients requiring short-term hemodialysis, such as those with acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report effective blood flow for dialysis and highlight design features that influence infection rates and mechanical complications.
What complications have been reported?
Safety data indicate risks of catheter-related bloodstream infections and mechanical issues like occlusion, particularly with femoral site placement.
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.