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modification to nipro safe touch safety fistula needle
Nipro Medical
Summary: The Nipro Safe Touch Safety Fistula Needle is a medical device used in dialysis procedures to access the patient's blood. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K032777 ↗
Decision Date
November 14, 2003
Product Code
FOZ
Device Class
Class 2
Evidence
0 studies
The Nipro Safe Touch Safety Fistula Needle was cleared through the FDA 510k pathway on November 14, 2003. It is manufactured by Nipro Medical and classified as a Class 2 device.
What It Is
The Nipro Safe Touch Safety Fistula Needle is a specialized needle designed for use in hemodialysis procedures. It features a safety mechanism to prevent needlestick injuries, enhancing safety for healthcare providers. The needle is used to access arteriovenous fistulas, which are surgically created connections between an artery and a vein, allowing for efficient blood flow during dialysis.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is essential in the management of patients with chronic kidney disease requiring hemodialysis. The needle's safety features make it particularly valuable in high-volume settings where multiple patients are treated daily.
Indications for Use
The Nipro Safe Touch Safety Fistula Needle is indicated for use in patients undergoing hemodialysis who have an arteriovenous fistula. It is designed to provide safe and effective vascular access for blood filtration and purification.
Practical Considerations
The needle is typically available in various gauges and lengths to accommodate different patient needs and fistula sizes. Compatibility with standard dialysis equipment is ensured, and proper technique is crucial to minimize complications such as infiltration or hematoma.
Frequently Asked Questions
What is the Nipro Safe Touch Safety Fistula Needle used for?
It is used for vascular access in hemodialysis procedures, specifically for patients with arteriovenous fistulas.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in hemodialysis patients with arteriovenous fistulas to facilitate blood access for dialysis treatment.
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.