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nipro arterial venous fistula needle agulha para fistula arterio-venosa aguja para fistula arterio venosa
Nipro Medical
Summary: The Nipro Arterial Venous Fistula Needle is used for vascular access during hemodialysis. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow in patients undergoing dialysis.
FDA Clearance Information
Pathway
510K
Number
K991623 ↗
Decision Date
August 9, 1999
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 9, 1999. Manufactured by Nipro Medical, it is classified as a Class 2 device under product code FIE.
What It Is
The Nipro Arterial Venous Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It features a sharp, beveled tip for easy insertion and a flexible tubing to connect to dialysis machines. Its design helps ensure efficient blood flow and minimizes trauma to the vascular access site.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is essential for patients with chronic kidney disease who require regular hemodialysis. The needle is used to establish a reliable vascular access point, which is crucial for effective dialysis treatment.
Indications for Use
The device is indicated for use in patients requiring vascular access for hemodialysis. It is specifically designed for accessing arteriovenous fistulas, which are surgically created connections between an artery and a vein.
Practical Considerations
The needles are available in various gauges to accommodate different patient needs and fistula sizes. Proper technique is essential to minimize complications such as infiltration or hematoma. Compatibility with standard dialysis equipment is ensured.
Frequently Asked Questions
What is the Nipro Arterial Venous Fistula Needle used for?
It is used for vascular access in patients undergoing hemodialysis, specifically for accessing arteriovenous fistulas.
What specialties typically use this device?
Nephrologists and dialysis nurses commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for vascular access in hemodialysis patients, specifically for use with arteriovenous fistulas.
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.