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exel secure touch safety a v fistula needle set
Exelint International
Summary: The Exel Secure Touch Safety AV Fistula Needle Set is a medical device used primarily in dialysis to access arteriovenous fistulas. It is commonly used by nephrologists and dialysis nurses to ensure safe and effective vascular access for hemodialysis patients.
FDA Clearance Information
Pathway
510K
Number
K003627 ↗
Decision Date
February 8, 2001
Product Code
FMI
Device Class
Class 2
Evidence
0 studies
The Exel Secure Touch Safety AV Fistula Needle Set was cleared via the FDA 510(k) pathway on February 8, 2001. Manufactured by Exelint International, it is classified as a Class 2 device under product code FMI.
What It Is
The Exel Secure Touch Safety AV Fistula Needle Set is designed for vascular access in patients undergoing hemodialysis. It features a safety mechanism to minimize the risk of needlestick injuries to healthcare providers. The needle is used to puncture the arteriovenous fistula, a surgically created connection between an artery and a vein, allowing for efficient blood flow during dialysis.
Clinical Applications
This device is primarily used in dialysis centers and hospitals to facilitate hemodialysis treatment. Nephrologists and dialysis nurses use it to access the patient's fistula, ensuring proper blood flow for dialysis. It is particularly important for patients with chronic kidney disease who require regular dialysis sessions. The safety features of the needle set help protect healthcare workers from accidental needlesticks.
Indications for Use
The FDA indications for this device involve its use in accessing arteriovenous fistulas for hemodialysis. It is intended for patients who require regular dialysis treatment due to kidney failure or chronic kidney disease.
Practical Considerations
The needle set typically comes in various sizes to accommodate different patient anatomies and fistula characteristics. It is compatible with standard dialysis equipment. Proper technique in inserting the needle and activating the safety mechanism is crucial for both patient safety and healthcare provider protection.
Frequently Asked Questions
What is Exel Secure Touch Safety AV Fistula Needle Set used for?
It is used for accessing arteriovenous fistulas in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device.
What are the FDA-cleared indications?
The device is indicated for accessing arteriovenous fistulas in patients requiring hemodialysis.
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.