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jms sysloc mini a v fistula needle set v4 jms sysloc mini apheresis needle set v4
Jms North America
Summary: The jms sysloc mini a v fistula needle set v4 is used for vascular access in dialysis and apheresis procedures. It is primarily used by nephrologists and dialysis nurses for patients requiring regular dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K142564 ↗
Decision Date
December 23, 2014
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on December 23, 2014. Manufactured by Jms North America, it is classified as a Class 2 medical device under product code FIE.
What It Is
The jms sysloc mini a v fistula needle set v4 is a specialized needle set designed for creating vascular access in patients undergoing dialysis or apheresis. It includes a needle and tubing system that allows for efficient blood flow during these procedures. The design aims to minimize discomfort and reduce the risk of complications such as infiltration or hematoma.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients with chronic kidney disease requiring hemodialysis. It is also used in apheresis procedures, which involve the separation and removal of blood components. Nephrologists, dialysis nurses, and apheresis specialists frequently use this device to ensure reliable vascular access in adult and pediatric patients.
Indications for Use
The device is indicated for use in patients who require vascular access for dialysis or apheresis. It is suitable for those with arteriovenous fistulas, a common access point for these procedures.
Practical Considerations
The needle set is available in various sizes to accommodate different patient anatomies and access sites. It is compatible with standard dialysis and apheresis equipment. Clinicians should be trained in proper insertion techniques to minimize complications.
Frequently Asked Questions
What is jms sysloc mini a v fistula needle set v4 used for?
It is used for vascular access in dialysis and apheresis procedures.
What specialties typically use this device?
Nephrology and apheresis specialists, including dialysis nurses, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for creating vascular access in patients undergoing dialysis or apheresis, particularly those with arteriovenous fistulas.
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.