📊 Evidence-Based Reference
Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits
Summary: The Amecath and Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits are used for temporary vascular access in hemodialysis. Cleared by the FDA via the 510(k) pathway, these devices are supported by 10 studies, though none directly related to the device.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K110793 ↗
Decision Date ?
December 16, 2011
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Amecath and Uniqath catheters were cleared by the FDA through the 510(k) pathway on December 16, 2011. Manufactured by Ameco Medical Industries, these devices are classified as Class 2 under product code MPB.
What It Is
These catheters are designed for short-term hemodialysis access, providing a conduit for blood to be removed, filtered, and returned to the body. They are intended for use in patients requiring temporary dialysis access.
FDA-Cleared Indications
- Temporary vascular access for hemodialysis.
- Use as a non-implanted hemodialysis catheter when short-term dialysis access is required.
Clinical Applications
- Hemodialysis through temporary central venous access.
- Dialysis access while a patient is awaiting placement or maturation of permanent vascular access.
- Short-term dialysis access during hospitalization when immediate hemodialysis is needed.
Evidence Summary
The literature includes 10 studies, none of which directly evaluate the Amecath or Uniqath catheters. The studies span various topics related to soft robotics and materials science, published between 2023 and 2024.
Reported Outcomes
Published studies report advancements in soft robotics and materials science, but none directly assess the clinical outcomes of the Amecath or Uniqath catheters. Therefore, specific efficacy findings for these devices are not available from the provided evidence.
Safety Profile
Reported complications include no direct safety data from the provided studies, as they do not focus on the Amecath or Uniqath catheters. Further research is needed to determine specific safety outcomes.
Evidence Limitations
The current evidence lacks direct studies on the Amecath and Uniqath catheters, highlighting a gap in clinical research. Future studies should focus on device-specific outcomes and safety to provide comprehensive data.
Practical Considerations
- These are short-term, non-implanted catheters and are not a substitute for a permanent arteriovenous fistula or graft when long-term dialysis access is needed.
- Access is generally obtained through a central vein, such as the internal jugular, femoral, or subclavian vein, using sterile technique and imaging guidance when appropriate.
- The specific catheter length, diameter, and kit contents depend on the product configuration and clinical access site; users should consult the device labeling.
- Potential complications include bleeding, infection, thrombosis, catheter malposition, vessel injury, air embolism, and inadequate dialysis flow.
- MRI compatibility and conditions are configuration-specific and should be confirmed in the manufacturer's labeling before MRI.
Frequently Asked Questions
What are the clinical indications for Amecath and Uniqath catheters?
These catheters are indicated for short-term hemodialysis access in patients requiring temporary vascular access.
What outcomes have been reported in clinical studies?
No specific outcomes for these catheters are reported in the provided studies.
What complications have been reported?
No specific complications for these catheters are reported in the provided studies.
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.