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tops dispos infusion set hemodialysis
Top Surgical Manufacturers
Summary: The tops dispos infusion set hemodialysis is a medical device used in hemodialysis procedures to facilitate vascular access. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K841119 ↗
Decision Date
April 20, 1984
Product Code
KNZ
Device Class
Class 2
Evidence
0 studies
The tops dispos infusion set hemodialysis was cleared through the FDA 510(k) pathway on April 20, 1984. Manufactured by Top Surgical Manufacturers, it is classified as a Class 2 device under product code KNZ.
What It Is
The tops dispos infusion set hemodialysis is a disposable medical device designed for use in hemodialysis, a procedure to filter waste and excess fluids from the blood when the kidneys are not functioning properly. The device typically includes components such as needles and tubing that connect to the dialysis machine, ensuring safe and efficient blood flow during treatment. Its disposable nature helps reduce the risk of infection and cross-contamination.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease undergo regular hemodialysis. Nephrologists and dialysis nurses utilize this infusion set to establish vascular access, which is critical for the effective removal of toxins and fluids from the bloodstream. It is suitable for adult and pediatric patients requiring dialysis, providing a reliable means of access for repeated treatments.
Indications for Use
The FDA indications for this device include its use in patients requiring hemodialysis due to renal failure. It is intended for individuals who need regular dialysis treatments to manage kidney function and maintain fluid and electrolyte balance.
Practical Considerations
Clinicians should consider the appropriate sizing of the infusion set components to match the patient's vascular access requirements. Compatibility with various dialysis machines should be verified to ensure seamless integration. Proper technique in insertion and maintenance is essential to minimize complications such as infection or clotting.
Frequently Asked Questions
What is tops dispos infusion set hemodialysis used for?
It is used to facilitate vascular access during hemodialysis procedures for patients with kidney failure.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis due to renal failure.
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.