đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Access an arteriovenous fistula for hemodialysis.
- Provide vascular access for connection to the extracorporeal dialysis circuit.
Clinical Applications
- Cannulation of a mature arteriovenous fistula before a hemodialysis treatment.
- Establishing arterial and venous access points between an arteriovenous fistula and a dialysis machine.
- Repeated vascular access during ongoing hemodialysis care for patients with kidney failure or advanced chronic kidney disease.
Practical Considerations
- The needle set is intended for single use and should be handled using standard aseptic technique to reduce contamination and infection risk.
- Available needle sizes and configurations should be selected according to the patient's fistula, vessel characteristics and dialysis prescription.
- Proper cannulation technique is important to reduce infiltration, hematoma, bleeding and damage to the fistula.
- The device is intended for connection to a hemodialysis circuit; users should confirm compatibility with the dialysis equipment and bloodlines being used.
- This is a needle-based access device and is not an MRI implant. MRI conditions should be assessed for any connected tubing, clamps or other equipment before entering the scanner environment.
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.