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nipro safetouch tulip safety fistula needle
Nipro Medical
Summary: The Nipro SafeTouch Tulip Safety Fistula Needle is a medical device used in hemodialysis to access the vascular system. It is primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K071145 ↗
Decision Date
September 7, 2007
Product Code
MPB
Device Class
Class 2
Evidence
0 studies
The Nipro SafeTouch Tulip Safety Fistula Needle was cleared via the FDA 510k pathway on September 7, 2007. It is manufactured by Nipro Medical and classified as a Class 2 device.
What It Is
The Nipro SafeTouch Tulip Safety Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It features a safety mechanism to prevent needle-stick injuries, enhancing safety for healthcare providers. The needle is designed for repeated use in dialysis sessions, providing reliable vascular access.
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 requiring regular hemodialysis. The needle is used in procedures to establish and maintain vascular access, critical for effective dialysis treatment.
Indications for Use
The FDA indications for this device include use in patients requiring vascular access for hemodialysis. It is intended for patients with arteriovenous fistulas, a common access point for dialysis.
Practical Considerations
The Nipro SafeTouch Tulip Safety Fistula Needle comes in various sizes to accommodate different patient needs and fistula types. It is compatible with standard dialysis equipment, and proper technique is essential to ensure safety and efficacy during use.
Frequently Asked Questions
What is the Nipro SafeTouch Tulip Safety Fistula Needle used for?
It is used for vascular access in hemodialysis patients, specifically those with arteriovenous fistulas.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for hemodialysis, particularly those 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.