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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 510K
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.
Clinical Applications
This device is predominantly used in dialysis centers and hospitals by nephrologists and trained dialysis nurses. It is crucial for patients with chronic kidney disease requiring regular hemodialysis. The needle facilitates repeated vascular access, a necessity for the effective management of patients undergoing long-term dialysis treatment.
Indications for Use
The FDA indications suggest that this needle is intended for use in patients with established AV fistulas, typically those undergoing routine hemodialysis. It is suitable for adults with chronic renal failure who require reliable vascular access.
Practical Considerations
Clinicians should consider the appropriate needle gauge and length based on the patient's vascular anatomy and the dialysis prescription. Compatibility with standard dialysis equipment is expected, and proper technique is essential to minimize complications such as infiltration or hematoma.
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.