📋 FDA Reference
Nipro Safetouch Locktail Safety Fistula Needle
Summary: The Nipro SafeTouch Locktail Safety Fistula Needle is a medical device used in dialysis procedures to provide safe vascular access. It is primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093985 ↗
Decision Date ?
January 22, 2010
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The Nipro SafeTouch Locktail Safety Fistula Needle was cleared via the FDA 510(k) pathway on January 22, 2010. It is manufactured by Nipro Medical and classified as a Class 2 device under product code FIE.
What It Is
The Nipro SafeTouch Locktail Safety Fistula Needle is designed for use in hemodialysis to provide vascular access. It features a safety mechanism to reduce the risk of needlestick injuries, enhancing safety for healthcare providers. The needle is used to connect a patient's arteriovenous fistula to the dialysis machine, facilitating the exchange of blood for filtration.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Access to an arteriovenous fistula during dialysis treatment.
Clinical Applications
- Needle access to an established arteriovenous fistula for hemodialysis.
- Connecting fistula blood access to standard hemodialysis tubing and equipment.
- Repeated vascular access for patients receiving chronic hemodialysis.
- Hemodialysis vascular access in a hospital or outpatient dialysis setting.
Practical Considerations
- The needle is available in different gauges and configurations; selection depends on the fistula, prescribed blood-flow rate, and dialysis protocol.
- It should be used only by trained clinicians who understand arteriovenous fistula cannulation and the device's safety mechanism.
- Compatibility with dialysis bloodlines and connectors should be confirmed before use.
- This is a vascular-access needle, not a long-term indwelling access device; it is removed after the dialysis treatment unless the product labeling specifies otherwise.
- The FDA record provided does not establish MRI safety. MRI compatibility should be verified from the current manufacturer labeling before scanning.
Frequently Asked Questions
What is the Nipro SafeTouch Locktail Safety Fistula Needle used for?
It is used to provide safe vascular access for hemodialysis in patients with end-stage renal disease.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for hemodialysis in patients requiring regular dialysis treatments.
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.