📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for hemodialysis through an established arteriovenous fistula.
Clinical Applications
- Cannulation of an arteriovenous fistula before a hemodialysis treatment.
- Withdrawal of blood from the fistula into the dialysis circuit.
- Return of filtered blood from the dialysis circuit to the fistula.
- Repeated dialysis access in patients with a functioning surgically created arteriovenous fistula.
Practical Considerations
- The needle size and configuration should be selected according to the fistula, vessel anatomy, prescribed blood-flow rate, and dialysis access protocol.
- Insertion should be performed by trained dialysis or vascular-access personnel using appropriate skin preparation and fistula-cannulation technique.
- The needle must be connected to compatible dialysis bloodlines and secured to reduce movement during treatment.
- This is a single-use access needle; it is not intended to remain in the fistula between dialysis treatments.
- MRI safety depends on the specific needle materials and whether the needle is present in the patient. The product labeling and institutional MRI policy should be reviewed before MRI, and the needle should generally be removed after dialysis unless explicitly approved for the MRI environment.
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.