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nipro safetouch locktail safety fistula needle
Nipro Medical
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
510K
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.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is utilized by nephrologists and dialysis nurses to access the vascular system of patients with end-stage renal disease. The SafeTouch Locktail is particularly valuable in settings that prioritize safety and efficiency, and it is suitable for both chronic dialysis patients and those requiring temporary dialysis access.
Indications for Use
The FDA indications for this device include its use in providing vascular access for hemodialysis. It is intended for patients who require regular dialysis treatments, typically those with chronic kidney disease.
Practical Considerations
The Nipro SafeTouch Locktail Safety Fistula Needle is available in various gauge sizes to accommodate different patient needs and fistula sizes. It is compatible with standard dialysis equipment and requires proper technique to ensure secure and effective access. Clinicians should be trained in its use to maximize safety and efficacy.
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.