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bionics arterial venous fistula needle
Cordis
Summary: The Bionics Arterial Venous Fistula Needle by Cordis is used in dialysis to access the bloodstream. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K801354 ↗
Decision Date
July 8, 1980
Product Code
KOC
Device Class
Class 2
Evidence
0 studies
The Bionics Arterial Venous Fistula Needle was cleared through the FDA 510(k) pathway on July 8, 1980. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Bionics Arterial Venous Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It facilitates efficient blood flow between the patient and the dialysis machine. The needle is typically made of biocompatible materials and is designed to minimize discomfort and complications during insertion.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients with chronic kidney disease requiring hemodialysis. Nephrologists and dialysis nurses use it to establish vascular access in patients with mature arteriovenous fistulas. It is essential for ensuring effective dialysis treatment by providing a reliable and safe access point.
Indications for Use
The needle is indicated for use in patients requiring vascular access for hemodialysis. It is specifically designed for those with established arteriovenous fistulas, which are surgically created connections between an artery and a vein.
Practical Considerations
The needle is available in various sizes to accommodate different patient anatomies and fistula characteristics. It is important to select the appropriate size and ensure proper technique to minimize the risk of complications such as infiltration or hematoma.
Frequently Asked Questions
What is the Bionics Arterial Venous Fistula Needle used for?
It is used for accessing arteriovenous fistulas in patients undergoing hemodialysis.
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?
It is indicated for use in patients requiring vascular access for hemodialysis, specifically those with established 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.