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
510K
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.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is particularly relevant for nephrologists and dialysis nurses who manage patients with chronic kidney disease requiring regular dialysis. The needle set is used in patients with established AV fistulas, ensuring safe and effective vascular access for dialysis sessions.
Indications for Use
The device is indicated for use in patients who require vascular access for hemodialysis. It is specifically designed for those with arteriovenous fistulas, a common access point for long-term dialysis treatment.
Practical Considerations
The needle set comes in various sizes to accommodate different patient anatomies and fistula characteristics. It is compatible with standard dialysis equipment. Proper technique is crucial to minimize complications such as infiltration or hematoma formation.
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.