📋 FDA Reference
Jms Harmony a V Fistula Needle Set
Jms North America
Summary: The JMS Harmony A V Fistula Needle Set is a medical device used in hemodialysis procedures to access the vascular system. It is primarily used by nephrologists and dialysis nurses to facilitate efficient and safe dialysis treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151017 ↗
Decision Date ?
May 13, 2015
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The JMS Harmony A V Fistula Needle Set was cleared through the FDA 510k pathway on May 13, 2015. Manufactured by JMS North America, it is classified as a Class 2 device under product code FIE.
What It Is
The JMS Harmony A V Fistula Needle Set is designed for use in hemodialysis, providing a means to access a patient's arteriovenous (A V) fistula. It consists of a needle, tubing, and connectors that facilitate the transfer of blood to and from the dialysis machine. This device is essential for patients undergoing regular dialysis, ensuring a reliable and safe connection to the vascular system.
FDA-Cleared Indications
- For vascular access during hemodialysis.
- For use with an established arteriovenous fistula.
- For access of the vascular system to allow blood to be withdrawn for dialysis and returned after treatment.
Clinical Applications
- Needle access of an arteriovenous fistula before a hemodialysis session.
- Connection of fistula blood access to standard hemodialysis blood tubing.
- Withdrawal of blood from the fistula for extracorporeal dialysis.
- Return of dialyzed blood to the fistula during hemodialysis.
Practical Considerations
- The set is intended for trained dialysis professionals and requires sterile technique and careful cannulation of the fistula.
- Available needle sizes and configurations should be selected based on the patient's fistula, prescribed blood-flow rate, and dialysis equipment.
- The set should be checked for package integrity, leaks, and secure connections before use.
- Potential complications include infiltration, bleeding, hematoma, infection, thrombosis, and inadequate blood flow.
- The FDA record and supplied labeling should be consulted for MRI information; do not assume the needle set is MRI safe or MRI conditional.
Frequently Asked Questions
What is the JMS Harmony A V Fistula Needle Set used for?
It is used to access the vascular system of patients undergoing hemodialysis, specifically through an arteriovenous fistula.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring hemodialysis, specifically those 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.