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Nipro Safetouch Tulip Safety Fistula Needle
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 ?
510(k)
Number ?
K071145 ↗
Decision Date ?
September 7, 2007
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Access to an arteriovenous fistula during hemodialysis treatment.
Clinical Applications
- Cannulation of an arteriovenous fistula for hemodialysis.
- Establishing arterial and venous access for an extracorporeal hemodialysis circuit.
- Repeated vascular access during scheduled hemodialysis sessions, according to the product labeling and facility protocol.
- Use by trained dialysis healthcare professionals in hospitals, dialysis centers, and other qualified clinical settings.
Practical Considerations
- The needle is available in different sizes and configurations; selection depends on fistula characteristics, prescribed blood-flow requirements, and dialysis-unit protocol.
- It is intended for use with compatible hemodialysis blood tubing and equipment by trained healthcare professionals.
- The safety mechanism should be activated and handled according to the manufacturer's instructions to reduce needlestick risk.
- Do not use if the package is damaged, the device is expired, or sterility is compromised; follow labeling regarding single-use or reuse.
- MRI safety should not be assumed from the 510(k) clearance. Confirm the exact model's MR Safe, MR Conditional, or MR Unsafe status in the current manufacturer labeling before MRI exposure.
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.