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jms a v fistula needle set accordion type
Jms
Summary: The JMS A V Fistula Needle Set is used for vascular access in hemodialysis patients. It is typically used by nephrologists and dialysis nurses in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K002352 ↗
Decision Date
September 6, 2001
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The JMS A V Fistula Needle Set received FDA clearance through the 510(k) pathway on September 6, 2001. It is manufactured by JMS and is classified as a Class 2 device.
What It Is
The JMS A V Fistula Needle Set is a medical device designed for vascular access in patients undergoing hemodialysis. It features an accordion-type design, which may enhance ease of use and patient comfort. The device is typically used to access arteriovenous fistulas, which are surgically created connections between an artery and a vein, providing a reliable site for repeated needle insertions.
Clinical Applications
This needle set is commonly used in dialysis centers and hospitals for patients requiring regular hemodialysis. Nephrologists and dialysis nurses use it to establish vascular access, which is crucial for the efficient removal and return of blood during dialysis sessions. The device is particularly relevant for patients with chronic kidney disease who have an arteriovenous fistula as their primary access site.
Indications for Use
The device is indicated for use in patients who require vascular access for hemodialysis. It is suitable for those with an arteriovenous fistula, a common vascular access method for long-term dialysis treatment.
Practical Considerations
The JMS A V Fistula Needle Set is typically available in various gauge sizes to accommodate different patient needs. Compatibility with standard dialysis equipment is expected, and clinicians should be trained in proper needle insertion techniques to minimize complications such as infiltration or hematoma.
Related Literature
The linked study evaluated hemolysis and blood trauma associated with a novel subcutaneous vascular access system for hemodialysis. It compared the system to traditional access methods, highlighting issues like blood flow and trauma. The study found that the novel system could potentially reduce complications, but limitations included its in vitro nature, necessitating further clinical trials for validation.
Frequently Asked Questions
What is the JMS A V Fistula Needle Set used for?
It is used for vascular access in patients undergoing hemodialysis, specifically for accessing arteriovenous fistulas.
What specialties typically use this device?
Nephrology and dialysis nursing specialties 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 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.