đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Access to an arteriovenous fistula for hemodialysis.
- Use in patients receiving hemodialysis who require cannulation of an established arteriovenous fistula.
Clinical Applications
- Cannulation of an arteriovenous fistula before a hemodialysis session.
- Establishing blood-flow access between an arteriovenous fistula and the dialysis circuit.
- Routine hemodialysis treatment in outpatient dialysis centers.
- Hemodialysis treatment in hospital settings.
Practical Considerations
- The device should be selected and used by trained healthcare professionals familiar with arteriovenous fistula assessment and cannulation.
- Available needle sizes and configurations may vary; selection depends on the fistula, patient anatomy, prescribed blood-flow requirements and dialysis-unit protocol.
- The set should be connected only to compatible dialysis bloodlines and equipment according to the manufacturer's instructions.
- Potential complications include pain, bleeding, hematoma, infiltration, infection, thrombosis and damage to the fistula; access-site assessment is required before and after use.
- MRI compatibility should not be assumed. Review the manufacturer's labeling and the complete set configuration before an MRI examination.
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.