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multi-lumen acute hemodialysis catheter for high volume infusions
Arrow International, Inc. (Subsidiary Of Teleflex, Inc.)
Summary: The multi-lumen acute hemodialysis catheter by Arrow International is designed for high volume infusions in dialysis. It is FDA 510k cleared with linked evidence from two studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway 510K
Number K143102 ↗
Decision Date July 24, 2015
Product Code NIE
Device Class Class 2
Evidence 0 studies
The multi-lumen acute hemodialysis catheter was cleared via the FDA 510k pathway on July 24, 2015. It is manufactured by Arrow International, Inc., a subsidiary of Teleflex, Inc., and is classified as a Class 2 medical device.
What It Is
This device is a multi-lumen catheter intended for acute hemodialysis, facilitating high volume infusions. It is used in clinical settings to provide vascular access for dialysis procedures.
Clinical Applications
Commonly used in acute settings where rapid and efficient dialysis is required, such as in patients with acute kidney injury or those requiring temporary dialysis access.
Evidence Summary
The available literature includes two studies linked to the device, though specific details on study types, sample sizes, and date ranges are not provided.
Reported Outcomes
Published studies report limited information on the efficacy of the multi-lumen acute hemodialysis catheter. Specific outcomes from the linked studies are not detailed in the provided evidence.
Safety Profile
Reported complications include limited safety data from the linked studies. Specific adverse events or complications are not detailed in the provided evidence.
Evidence Limitations
The evidence provided lacks detailed outcomes and safety data, highlighting a gap in comprehensive clinical evaluation. Further research is needed to establish the efficacy and safety profile of the device.
Frequently Asked Questions
What are the clinical indications for multi-lumen acute hemodialysis catheter?
The device is indicated for use in acute hemodialysis requiring high volume infusions.
What outcomes have been reported in clinical studies?
Specific findings from the linked studies are not detailed in the provided evidence.
What complications have been reported?
Safety data from the linked studies are not detailed, indicating a need for further research.
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.