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jms a v fistula needle set wing eater model 14g-18g
Jms
Summary: The JMS A V Fistula Needle Set Wing Eater Model 14G-18G is used for vascular access in hemodialysis patients. It is primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K010406 ↗
Decision Date
June 20, 2001
Product Code
FOZ
Device Class
Class 2
Evidence
0 studies
The JMS A V Fistula Needle Set was cleared via the FDA 510(k) pathway on June 20, 2001. It is manufactured by JMS and classified as a Class II device.
What It Is
The JMS A V Fistula Needle Set Wing Eater Model is a medical device designed for vascular access in hemodialysis patients. It consists of a needle set with sizes ranging from 14G to 18G, allowing for effective blood flow during dialysis. The device is used to puncture arteriovenous fistulas, which are surgically created connections between an artery and a vein, facilitating efficient blood filtration.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for patients with chronic kidney disease requiring regular dialysis. Nephrologists and dialysis nurses use it to ensure reliable and repeated vascular access, which is crucial for effective dialysis treatment. The needle set is specifically designed to minimize trauma and maximize blood flow during the procedure.
Indications for Use
The JMS A V Fistula Needle Set is indicated for use in patients requiring hemodialysis access. It is suitable for those with arteriovenous fistulas, providing a reliable means to access the bloodstream for dialysis sessions.
Practical Considerations
The needle set is available in sizes from 14G to 18G, allowing for flexibility based on patient needs and vascular access characteristics. It is compatible with standard dialysis equipment and requires careful handling to minimize complications such as bleeding or infection.
Related Literature
The linked study evaluated hemolysis and blood trauma in a novel vascular access system for hemodialysis. It highlighted the challenges of current access technologies, such as insufficient blood flow and thrombosis. The study focused on the LifeSite System, which uses a 14G needle, similar to the JMS needle set, and found it to be a viable alternative for vascular access. However, the study's limitations include its in vitro nature, which may not fully replicate clinical conditions.
Frequently Asked Questions
What is the JMS A V Fistula Needle Set used for?
It is used for vascular access in hemodialysis patients, allowing efficient blood flow during dialysis sessions.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis access, 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.