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jms sysloc mini a v fistula needle set and apheresis needle set
Jms North America
Summary: The JMS Sysloc Mini A V Fistula Needle Set is used for vascular access in dialysis and apheresis procedures. It is primarily utilized by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K051814 ↗
Decision Date
August 4, 2005
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 4, 2005, by JMS North America. It is classified as a Class 2 device under product code FIE.
What It Is
The JMS Sysloc Mini A V Fistula Needle Set is a medical device designed for creating vascular access in patients undergoing dialysis or apheresis. It consists of a needle and tubing system that facilitates the connection between the patient's circulatory system and the dialysis machine. The device is engineered to minimize discomfort and optimize blood flow during treatment.
Clinical Applications
This device is commonly used in nephrology and hematology settings, particularly in dialysis centers and hospitals. It is essential for patients with chronic kidney disease requiring hemodialysis or those undergoing apheresis for conditions such as autoimmune disorders. The needle set is used by healthcare professionals trained in vascular access techniques.
Indications for Use
The FDA-cleared indications for this device include its use in patients needing vascular access for dialysis or apheresis. It is suitable for individuals with end-stage renal disease or those requiring blood component separation.
Practical Considerations
The JMS Sysloc Mini A V Fistula Needle Set comes in various sizes to accommodate different patient anatomies. It is compatible with standard dialysis machines and requires careful insertion technique to ensure proper function and patient comfort.
Frequently Asked Questions
What is JMS Sysloc Mini A V Fistula Needle Set used for?
It is used for vascular access in dialysis and apheresis procedures.
What specialties typically use this device?
Nephrology and hematology, particularly by nephrologists and dialysis nurses.
What are the FDA-cleared indications?
For vascular access in dialysis and apheresis in patients with renal disease or requiring blood component separation.
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.