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shelly protected av fistula needle
Diasol
Summary: The Shelly Protected AV Fistula Needle is a medical device used in dialysis procedures to access arteriovenous fistulas. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway 510K
Number K993187 ↗
Decision Date November 5, 1999
Product Code FPA
Device Class Class 2
Evidence 0 studies
The Shelly Protected AV Fistula Needle was cleared through the FDA 510(k) pathway on November 5, 1999. It is manufactured by Diasol and is classified as a Class II device.
What It Is
The Shelly Protected AV Fistula Needle is designed for safe and effective access to arteriovenous fistulas during hemodialysis. It features a protective mechanism to minimize needlestick injuries, enhancing safety for healthcare providers. The needle is typically used to create a reliable vascular access point for patients undergoing regular dialysis treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where patients with chronic kidney disease receive hemodialysis. Nephrologists and dialysis nurses use it to access AV fistulas, which are surgically created connections between an artery and a vein. It is crucial for patients who require long-term dialysis, ensuring efficient blood flow during the procedure.
Indications for Use
The FDA indications for the Shelly Protected AV Fistula Needle involve its use in accessing arteriovenous fistulas for dialysis. It is intended for patients with end-stage renal disease who need regular hemodialysis sessions.
Practical Considerations
The needle is available in various sizes to accommodate different patient anatomies and fistula characteristics. It is compatible with standard dialysis equipment and requires proper technique to ensure effective and safe access. Training in its use is essential for minimizing complications.
Frequently Asked Questions
What is the Shelly Protected AV Fistula Needle 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 needing 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.