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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 ?
510(k)
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.
FDA-Cleared Indications
- Accessing arteriovenous fistulas for hemodialysis
- Providing vascular access for blood removal and return during dialysis treatment
Clinical Applications
- Needle access to a mature arteriovenous fistula during maintenance hemodialysis
- Arterial-line access for withdrawing blood from the dialysis patient
- Venous-line access for returning filtered blood to the patient
- Use in dialysis centers or hospitals by trained healthcare professionals
Practical Considerations
- Available needle sizes may vary; selection should match the fistula, prescribed blood-flow rate, and dialysis circuit requirements.
- The device is intended for use with standard hemodialysis equipment and must be handled using trained fistula-cannulation technique.
- The protective mechanism is intended to reduce occupational needlestick risk but does not eliminate the need for standard sharps-safety practices.
- Do not use if the package is damaged, the device is expired, or sterility is compromised.
- MRI safety should not be assumed from the FDA clearance record; check the current manufacturer labeling for the specific needle configuration before MRI use.
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.