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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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for hemodialysis through an established arteriovenous fistula.
- Use in patients who require hemodialysis and have a surgically created arteriovenous fistula.
Clinical Applications
- Needle cannulation of an arteriovenous fistula before hemodialysis.
- Establishing arterial and venous blood access for connection to standard dialysis tubing and equipment.
- Repeated hemodialysis access in patients with chronic kidney disease or end-stage kidney disease who have a functioning arteriovenous fistula.
Practical Considerations
- The set is intended for single use and should be selected in an appropriate needle size and configuration for the patient's fistula and dialysis system.
- The non-safety and safety series have different handling features; staff should follow the product instructions and facility protocols for needle insertion, activation and disposal.
- Correct cannulation technique is important to reduce infiltration, bleeding, hematoma, infection and damage to the fistula.
- Compatibility with the dialysis machine, blood tubing and connectors should be confirmed before use.
- MRI safety information is not established by the FDA record provided. The needle should be removed before MRI unless the complete product labeling confirms that it is MR safe or MR conditional.
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.