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jms caveo a v fistula needle set
Jms North America
Summary: The JMS Caveo A V Fistula Needle Set is a medical device used in dialysis procedures to access arteriovenous fistulas. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway 510K
Number K251877 ↗
Decision Date August 15, 2025
Product Code FIE
Device Class Class 2
Evidence 0 studies
The JMS Caveo A V Fistula Needle Set was cleared through the FDA 510(k) pathway on August 15, 2025. Manufactured by JMS North America, it is classified as a Class 2 device under product code FIE.
What It Is
The JMS Caveo A V Fistula Needle Set is designed for use in hemodialysis, providing a reliable means of accessing an arteriovenous fistula. The needle set typically includes a sharp needle for insertion and a flexible tubing system to connect to the dialysis machine. Its design aims to minimize patient discomfort and ensure efficient blood flow during dialysis sessions.
Clinical Applications
This device is commonly used in outpatient dialysis centers and hospital settings where patients with chronic kidney disease undergo regular hemodialysis. Nephrologists and dialysis nurses use it to establish vascular access in patients with arteriovenous fistulas, a common vascular access point for long-term dialysis treatment.
Indications for Use
The device is indicated for patients requiring vascular access for hemodialysis, specifically those with an arteriovenous fistula. It is suitable for adults with chronic kidney disease who need regular dialysis treatment.
Practical Considerations
The needle set is available in various sizes to accommodate different patient anatomies and fistula types. It is compatible with standard dialysis machines and should be used by trained healthcare professionals familiar with vascular access techniques.
Frequently Asked Questions
What is JMS Caveo A V Fistula Needle Set used for?
It is used for accessing arteriovenous fistulas in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in hemodialysis patients 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.