đź“‹ FDA Reference
Jms Blunt a V Fistula Needle Set with Site Preparation Tool Model 820-5300 820-6300 and 820-7300
Jms North America
Summary: The JMS Blunt AV Fistula Needle Set is used for vascular access in dialysis patients. It is primarily utilized by nephrologists and dialysis nurses to facilitate hemodialysis treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093637 ↗
Decision Date ?
February 9, 2010
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The JMS Blunt AV Fistula Needle Set was cleared via the FDA 510(k) pathway on February 9, 2010. It is manufactured by JMS North America and is classified as a Class 2 device.
What It Is
The JMS Blunt AV Fistula Needle Set is designed for creating vascular access in patients undergoing hemodialysis. It includes a blunt needle to reduce the risk of vessel damage and a site preparation tool to ensure proper insertion. This device is essential in maintaining the patency and functionality of arteriovenous fistulas, which are commonly used access points for dialysis.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients with an established arteriovenous fistula.
- Cannulation of an arteriovenous fistula using the indicated blunt fistula needle set and site preparation tool.
Clinical Applications
- Accessing an established AV fistula before a hemodialysis session.
- Connecting fistula vascular access to standard hemodialysis tubing and equipment.
- Preparing the fistula access site before needle insertion.
- Repeated vascular access for patients receiving maintenance hemodialysis.
Practical Considerations
- The set is available in models 820-5300, 820-6300, and 820-7300; confirm the selected model and needle specifications before use.
- Use only with an appropriate, established AV fistula and compatible dialysis equipment.
- Proper cannulation technique is important to reduce infiltration, hematoma, bleeding, infection, and damage to the fistula.
- The device is intended for single-use access; follow the product labeling and facility policy for handling and disposal.
- This is not an implanted device and does not remain in the body. MRI compatibility is generally not a relevant use condition, but the complete product labeling should be checked if MRI is planned while any component remains present.
Frequently Asked Questions
What is the JMS Blunt AV Fistula Needle Set used for?
It is used for vascular access in patients undergoing hemodialysis, specifically for those with arteriovenous fistulas.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for hemodialysis, particularly those with AV 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.