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gambro a-v fistula needle set
Gambro
Summary: The Gambro A-V Fistula Needle Set is used in hemodialysis to access the bloodstream through an arteriovenous fistula. It is primarily used by nephrologists and dialysis nurses in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K802956 ↗
Decision Date
December 22, 1980
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Gambro A-V Fistula Needle Set was cleared through the FDA 510(k) pathway on December 22, 1980. Manufactured by Gambro, it is classified as a Class 2 medical device.
What It Is
The Gambro A-V Fistula Needle Set is a medical device designed to provide vascular access for hemodialysis. It consists of a needle and tubing system that connects to the dialysis machine, allowing blood to be drawn from and returned to the patient. The needle is inserted into an arteriovenous fistula, a surgically created connection between an artery and a vein, which facilitates efficient blood flow during dialysis.
Clinical Applications
This device is commonly used in dialysis centers for patients with chronic kidney disease requiring regular hemodialysis. Nephrologists and dialysis nurses use it to establish a reliable vascular access point. It is essential for patients who have undergone surgical creation of an arteriovenous fistula, providing a stable and efficient means of accessing the bloodstream.
Indications for Use
The Gambro A-V Fistula Needle Set is indicated for use in patients requiring hemodialysis, particularly those with an arteriovenous fistula. It is designed to facilitate the repeated vascular access necessary for dialysis treatments.
Practical Considerations
The needle set typically comes in various sizes to accommodate different patient anatomies and fistula characteristics. Compatibility with standard dialysis machines is ensured, and proper insertion technique is crucial to minimize complications such as infiltration or hematoma.
Frequently Asked Questions
What is the Gambro A-V Fistula Needle Set used for?
It is used to access the bloodstream in patients undergoing hemodialysis through an arteriovenous fistula.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in dialysis centers.
What are the FDA-cleared indications?
It is indicated for vascular access in hemodialysis patients with an arteriovenous fistula.
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.