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jms harmony a v fistula needle set
Jms North America
Summary: The JMS Harmony A V Fistula Needle Set is a medical device used in hemodialysis procedures to access the vascular system. It is primarily used by nephrologists and dialysis nurses to facilitate efficient and safe dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K151017 ↗
Decision Date
May 13, 2015
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The JMS Harmony A V Fistula Needle Set was cleared through the FDA 510k pathway on May 13, 2015. Manufactured by JMS North America, it is classified as a Class 2 device under product code FIE.
What It Is
The JMS Harmony A V Fistula Needle Set is designed for use in hemodialysis, providing a means to access a patient's arteriovenous (A V) fistula. It consists of a needle, tubing, and connectors that facilitate the transfer of blood to and from the dialysis machine. This device is essential for patients undergoing regular dialysis, ensuring a reliable and safe connection to the vascular system.
Clinical Applications
This device is commonly used in dialysis centers and hospitals, where patients with chronic kidney disease receive regular hemodialysis treatments. Nephrologists and dialysis nurses use it to access the A V fistula, a surgically created connection between an artery and a vein, which is crucial for efficient dialysis. It is particularly important for patients who require long-term dialysis access.
Indications for Use
The FDA indications for the JMS Harmony A V Fistula Needle Set are for use in patients who require vascular access for hemodialysis. It is specifically designed for those with an A V fistula, a common access point for dialysis treatment.
Practical Considerations
The needle set comes in various sizes to accommodate different patient needs and fistula characteristics. It is compatible with standard dialysis equipment and requires careful technique to ensure proper insertion and minimize complications such as infiltration or infection.
Frequently Asked Questions
What is the JMS Harmony A V Fistula Needle Set used for?
It is used to access the vascular system of patients undergoing hemodialysis, specifically through an arteriovenous fistula.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring hemodialysis, specifically those with an arteriovenous fistula.
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.