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dora disposable a v fistula needle sets
Bain Medical Equipment (Guangzhou)
Summary: The Dora Disposable A V Fistula Needle Sets are used in dialysis procedures to access the arteriovenous fistula. They are primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K213015 ↗
Decision Date
April 8, 2022
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 8, 2022. It is manufactured by Bain Medical Equipment (Guangzhou) and is classified as a Class 2 device under product code FIE.
What It Is
The Dora Disposable A V Fistula Needle Sets are medical devices designed for vascular access in hemodialysis. These needle sets facilitate the connection between the dialysis machine and the patient's bloodstream through an arteriovenous fistula. The needle sets are disposable, reducing the risk of infection and ensuring patient safety during repeated dialysis sessions.
Clinical Applications
These needle sets are commonly used in dialysis centers and hospitals where patients with chronic kidney disease undergo hemodialysis. Nephrologists and dialysis nurses use them to establish vascular access in patients with an arteriovenous fistula, a common access point for long-term dialysis. The device is crucial for efficient and safe blood filtration during dialysis sessions.
Indications for Use
The FDA-cleared indications for this device include its use in accessing arteriovenous fistulas for hemodialysis. It is intended for patients requiring regular dialysis due to kidney failure or chronic kidney disease.
Practical Considerations
The needle sets come in various sizes to accommodate different patient anatomies and fistula characteristics. Compatibility with standard dialysis machines is ensured, and proper technique in needle insertion is essential to minimize complications such as infiltration or hematoma.
Frequently Asked Questions
What is Dora Disposable A V Fistula Needle Sets used for?
They are used for vascular access in hemodialysis, connecting the dialysis machine to the patient's bloodstream through an arteriovenous fistula.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in accessing arteriovenous fistulas for hemodialysis in patients with kidney failure or 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.