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renaflo avf set for hemodialysis
Renal Systems
Summary: The Renaflo AVF Set for Hemodialysis is a medical device used to facilitate vascular access for hemodialysis treatment. It is typically used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K834510 ↗
Decision Date
February 4, 1984
Product Code
KNZ
Device Class
Class 2
Evidence
0 studies
The Renaflo AVF Set for Hemodialysis was cleared through the FDA 510k pathway on February 4, 1984. Manufactured by Renal Systems, it is classified as a Class 2 device under product code KNZ.
What It Is
The Renaflo AVF Set for Hemodialysis is designed to provide reliable vascular access for patients undergoing hemodialysis. It typically includes components such as needles, tubing, and connectors that facilitate the connection to the dialysis machine. The device is crucial for patients with chronic kidney disease requiring regular dialysis sessions, ensuring efficient and safe blood filtration.
Clinical Applications
This device is commonly used in nephrology and dialysis centers to establish and maintain vascular access in patients requiring hemodialysis. It is particularly important for patients with end-stage renal disease (ESRD) who need regular dialysis treatments. The device is used in both inpatient and outpatient settings, and is essential for maintaining the patient's dialysis schedule and overall treatment plan.
Indications for Use
The device is indicated for use in patients who require hemodialysis, typically those with chronic kidney disease or end-stage renal disease. It facilitates the necessary vascular access for the dialysis process, allowing for efficient blood filtration and waste removal.
Practical Considerations
The Renaflo AVF Set is available in various sizes to accommodate different patient anatomies and access sites. It is compatible with standard dialysis machines and requires careful handling to prevent complications such as infection or thrombosis. Clinicians should be familiar with the insertion and maintenance techniques to ensure optimal performance.
Frequently Asked Questions
What is the Renaflo AVF Set for Hemodialysis used for?
It is used to provide vascular access for patients undergoing hemodialysis treatment.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for establishing vascular access in patients requiring hemodialysis, such as those with chronic kidney disease.
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.