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modification top ultra thinwall a-v fistula needle
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Summary: The Modification Top Ultra Thinwall A-V Fistula Needle is a medical device used primarily in dialysis procedures to access the arteriovenous fistula. It is used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K860449 ↗
Decision Date
February 26, 1986
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on February 26, 1986. It is manufactured by Top and classified as a Class 2 device under product code FIE.
What It Is
The Modification Top Ultra Thinwall A-V Fistula Needle is designed to provide vascular access for patients undergoing hemodialysis. It features a thin wall to allow for a higher flow rate of blood with a smaller gauge needle, minimizing discomfort for the patient. The needle is typically used to puncture the arteriovenous fistula, a surgically created connection between an artery and a vein.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease receive hemodialysis. Nephrologists and dialysis nurses use it to ensure efficient blood flow during dialysis sessions. It is particularly useful in patients with mature arteriovenous fistulas, providing reliable access with minimal trauma.
Indications for Use
The FDA indications suggest that this needle is intended for use in patients requiring vascular access for hemodialysis. It is suitable for those with established arteriovenous fistulas, a common access point for dialysis treatment.
Practical Considerations
The needle is available in various sizes to accommodate different patient needs and fistula characteristics. It is compatible with standard dialysis equipment. Proper technique is essential to avoid complications such as infiltration or hematoma.
Frequently Asked Questions
What is the Modification Top Ultra Thinwall A-V Fistula Needle used for?
It is used for vascular access in patients undergoing hemodialysis, specifically to access the arteriovenous fistula.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for hemodialysis, particularly those 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.