đź“‹ FDA Reference
Shelly Protected AV Fistula Needle
Diasol
Summary: The Shelly Protected AV Fistula Needle is a medical device used primarily in hemodialysis procedures. It is designed for safe and effective access to arteriovenous fistulas, commonly used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K992653 ↗
Decision Date ?
October 27, 1999
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The Shelly Protected AV Fistula Needle, manufactured by Diasol, received FDA 510k clearance on October 27, 1999. It is classified as a Class 2 device under product code FIE.
What It Is
The Shelly Protected AV Fistula Needle is a specialized needle designed for accessing arteriovenous (AV) fistulas, which are surgically created connections between an artery and a vein. This device is essential for hemodialysis, allowing for efficient blood flow from the patient to the dialysis machine. The 'protected' aspect likely refers to safety features that minimize needle-stick injuries and ensure secure placement during procedures.
FDA-Cleared Indications
- Access to an established arteriovenous fistula for hemodialysis.
- Use by trained healthcare professionals in dialysis or hospital settings according to the device labeling and instructions for use.
Clinical Applications
- Cannulation of an arteriovenous fistula before hemodialysis.
- Withdrawal of blood from an AV fistula for passage through a dialysis circuit.
- Return of dialyzed blood to the patient through an AV fistula.
- Repeated vascular access for patients receiving maintenance hemodialysis.
Practical Considerations
- The needle gauge and length should be selected by trained dialysis staff based on the fistula's size, depth, anatomy, and the dialysis prescription.
- Use requires assessment of fistula flow and careful cannulation technique to reduce infiltration, hematoma, bleeding, infection, and loss of access.
- The needle should be used only with compatible dialysis tubing and equipment, following the manufacturer's instructions for use.
- The protected design may reduce needlestick risk, but staff must follow institutional sharps-safety procedures.
- MRI safety should be confirmed from the current manufacturer labeling; do not assume the device is MR safe or MR conditional. The needle is intended for dialysis access, not long-term implantation.
Frequently Asked Questions
What is Shelly Protected AV Fistula Needle used for?
It is used for vascular access in patients undergoing hemodialysis, specifically accessing arteriovenous fistulas.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients with AV fistulas, primarily for hemodialysis access.
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.