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dimesol disposable av fistula needle set non-safety series and dimesol disposable av fistula needle set safety series
Dimesol
Summary: The Dimesol AV Fistula Needle Set is used for vascular access in dialysis patients. It is utilized by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K171505 ↗
Decision Date
May 17, 2018
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Dimesol AV Fistula Needle Set was cleared via the FDA 510(k) pathway on May 17, 2018. Manufactured by Dimesol, it is a Class 2 device under product code FIE.
What It Is
The Dimesol AV Fistula Needle Set is a medical device designed for creating vascular access in patients undergoing hemodialysis. It consists of a needle that is inserted into an arteriovenous fistula, a surgically created connection between an artery and a vein. The device is available in both safety and non-safety series, providing options for different clinical needs and preferences.
Clinical Applications
This device is primarily used in dialysis centers and hospitals for patients requiring regular hemodialysis. It is essential for nephrology specialists and dialysis nurses who manage patients with chronic kidney disease. The needle set facilitates efficient blood flow during dialysis sessions, which is critical for effective treatment outcomes.
Indications for Use
The device is indicated for use in patients who require vascular access for hemodialysis. It is suitable for individuals with end-stage renal disease who have an arteriovenous fistula.
Practical Considerations
The Dimesol AV Fistula Needle Set comes in various sizes to accommodate different patient anatomies and clinical needs. Compatibility with standard dialysis equipment is essential, and proper technique in needle insertion is crucial to minimize complications.
Related Literature
The linked study investigated the use of core needle biopsies in renal transplantation using an 18-G disposable needle system. It demonstrated a high success rate in obtaining sufficient renal tissue for diagnosis, with 99.5% of procedures completed successfully. The study highlighted the importance of accurate pathological diagnosis in managing transplant cases, though it was limited by its focus on a specific patient population and procedure.
Frequently Asked Questions
What is the Dimesol AV Fistula Needle Set used for?
It is used for vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties commonly use this device.
What are the FDA-cleared indications?
It is indicated for vascular access in patients with an arteriovenous fistula 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.