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nipro arterial venous fistula needle
Nissho
Summary: The Nipro Arterial Venous Fistula Needle is used in dialysis procedures to access the bloodstream. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K955182 ↗
Decision Date
June 4, 1996
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Nipro Arterial Venous Fistula Needle was cleared through the FDA 510k pathway on June 4, 1996. Manufactured by Nissho, it is classified as a Class 2 device under product code FIE.
What It Is
The Nipro Arterial Venous Fistula Needle is a medical device designed to provide vascular access for hemodialysis. It consists of a sharp, hollow needle that is inserted into a patient's arteriovenous fistula, a surgically created connection between an artery and a vein. This device facilitates the efficient transfer of blood to and from the dialysis machine, allowing for effective filtration and waste removal.
Clinical Applications
Commonly used in nephrology, this device is essential in dialysis centers and hospitals for patients with chronic kidney disease requiring hemodialysis. It is used in both outpatient and inpatient settings, primarily by nephrologists and dialysis nurses. The needle is crucial for patients with established arteriovenous fistulas, ensuring reliable and repeated vascular access during dialysis sessions.
Indications for Use
The FDA indications for this device include its use in patients requiring hemodialysis, particularly those with an established arteriovenous fistula. It is intended for individuals with end-stage renal disease who need regular dialysis treatments.
Practical Considerations
The Nipro Arterial Venous Fistula Needle typically comes in various sizes to accommodate different patient anatomies and fistula characteristics. It is important to select the appropriate size for each patient to minimize discomfort and ensure effective blood flow. Compatibility with standard dialysis equipment is generally expected.
Frequently Asked Questions
What is the Nipro Arterial Venous Fistula Needle used for?
It is used to provide vascular access for hemodialysis in patients with an arteriovenous fistula.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring hemodialysis with an established 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.