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arrow large-bore dual lumen hemodialysis kit
Arrow Intl.
Summary: The Arrow Large-Bore Dual Lumen Hemodialysis Kit is a medical device used for hemodialysis in patients requiring renal replacement therapy. It is typically used by nephrologists and dialysis nurses in both hospital and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K895417 ↗
Decision Date
January 3, 1990
Product Code
LFJ
Device Class
Class 2
Evidence
0 studies
The Arrow Large-Bore Dual Lumen Hemodialysis Kit was cleared through the FDA 510k pathway on January 3, 1990. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code LFJ.
What It Is
This device is a dual-lumen catheter system designed for hemodialysis, allowing for efficient blood flow during dialysis sessions. The large-bore design facilitates high flow rates, which is critical for effective dialysis treatment. It is typically inserted into a central vein, providing a temporary access point for patients undergoing renal replacement therapy.
Clinical Applications
Commonly used in nephrology, this device is essential for patients with acute or chronic kidney failure who require hemodialysis. It is used in both hospital settings and dialysis centers. The device is suitable for adult patients who need temporary vascular access, particularly when other forms of access are not available or feasible.
Indications for Use
The device is indicated for patients needing hemodialysis due to kidney failure. It is used to provide vascular access for blood removal, filtration, and return during dialysis sessions.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis machines and requires careful insertion and maintenance to prevent complications such as infection or thrombosis.
Frequently Asked Questions
What is the Arrow Large-Bore Dual Lumen Hemodialysis Kit used for?
It is used for providing vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in both hospital and outpatient dialysis settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis due to renal failure, providing temporary vascular access.
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.