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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 ?
510(k)
Number ?
K143102 ↗
Decision Date ?
July 24, 2015
Product Code ?
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
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.
FDA-Cleared Indications
- Temporary vascular access for acute hemodialysis.
- Use when high-volume blood flow is required for dialysis procedures.
- High-volume infusion through a multi-lumen catheter in an acute-care setting, as specified by the device labeling.
Clinical Applications
- Temporary hemodialysis access for hospitalized patients with acute kidney injury.
- Temporary dialysis access when a patient requires urgent or short-term renal replacement therapy.
- Withdrawal and return of blood during hemodialysis through separate catheter lumens.
- High-volume infusion through an available catheter lumen when permitted by the specific product labeling.
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.
Practical Considerations
- Catheter length, diameter, number of lumens and blood-flow capability vary by product configuration; selection should match the access site, patient anatomy and dialysis prescription.
- Common insertion sites include the internal jugular or femoral vein; subclavian access is generally avoided when future permanent dialysis access may be needed.
- Placement is typically performed using sterile technique and ultrasound and fluoroscopic guidance when appropriate.
- MRI compatibility is configuration-specific. Confirm the exact catheter model and manufacturer conditions before MRI; the catheter may also contain or be connected to components that require separate evaluation.
- Important risks include bleeding, infection, thrombosis, air embolism, vessel or organ injury, malposition and inadequate blood flow. The device is intended for temporary use, and the labeling should be checked for dwell-time limits and contraindications.
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.