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jms a v fistula needle set
Jms
Summary: The JMS A V Fistula Needle Set is a medical device used for vascular access in hemodialysis patients. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway
510K
Number
K990470 ↗
Decision Date
August 30, 1999
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The JMS A V Fistula Needle Set was cleared through the FDA 510(k) pathway on August 30, 1999. It is manufactured by Jms and classified as a Class 2 device under product code FIE.
What It Is
The JMS A V Fistula Needle Set is designed for use in hemodialysis, providing a reliable means of accessing the vascular system. The device typically includes a needle and tubing system that connects to the dialysis machine, allowing for efficient blood flow. This needle set is essential for patients with arteriovenous fistulas, which are surgically created connections between an artery and a vein, commonly used in long-term dialysis treatment.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is specifically designed for patients undergoing hemodialysis, particularly those with arteriovenous fistulas or grafts. The needle set facilitates the high blood flow rates required for effective dialysis, making it a critical component in the management of end-stage renal disease.
Indications for Use
The FDA indications for the JMS A V Fistula Needle Set are for use in patients requiring vascular access for hemodialysis. It is intended for those with established arteriovenous fistulas or grafts, providing a reliable method to access the bloodstream for dialysis treatment.
Practical Considerations
The needle set typically uses 15G needles, which are standard for accessing arteriovenous fistulas. Clinicians should be aware of the compatibility with the dialysis machine and ensure proper technique to minimize complications such as infiltration or hematoma. Proper training in needle insertion and securing techniques is essential.
Related Literature
The linked study evaluated hemolysis and blood trauma in a novel subcutaneous vascular access system for hemodialysis. It compared traditional access methods, including the use of 15G needles in AV fistulas, with a new system using a 14G needle. The study highlighted issues such as blood trauma and thrombosis associated with current technologies. However, limitations include its in vitro nature, which may not fully replicate clinical conditions.
Frequently Asked Questions
What is JMS A V Fistula Needle Set used for?
It is used for vascular access in hemodialysis, specifically for patients with arteriovenous fistulas or grafts.
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 vascular access in hemodialysis patients with arteriovenous fistulas or grafts.
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.