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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 for vascular access in hemodialysis. They are typically used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway
510K
Number
K163025 ↗
Decision Date
July 20, 2017
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on July 20, 2017. It is manufactured by Bain Medical Equipment (Guangzhou) and classified as a Class 2 medical device.
What It Is
The Dora Disposable A V Fistula Needle Sets are medical devices designed for use in hemodialysis procedures. They consist of needles specifically engineered to access arteriovenous (AV) fistulas, which are surgically created connections between an artery and a vein. These needles allow for the efficient transfer of blood to and from the dialysis machine, ensuring effective treatment.
Clinical Applications
These needle sets are primarily used in dialysis centers and hospitals where patients undergo regular hemodialysis. They are essential for patients with chronic kidney disease who require routine dialysis to manage their condition. Nephrologists and dialysis nurses use these devices to ensure safe and effective vascular access during the dialysis process.
Indications for Use
The FDA-cleared indications for this device are for use in patients requiring vascular access for hemodialysis. This includes individuals with end-stage renal disease or chronic kidney failure who need regular dialysis treatments.
Practical Considerations
The needle sets come in various sizes to accommodate different patient needs and fistula characteristics. Compatibility with standard dialysis equipment is a key consideration, and proper technique in needle insertion is crucial 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, allowing for the efficient transfer of blood to and from the dialysis machine.
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 vascular access for hemodialysis, such as those with end-stage renal 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.