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modification to jms a v fistula needle set
Jms
Summary: The modification to the JMS A V Fistula Needle Set is a Class 2 medical device used in dialysis access. It is FDA 510(k) cleared. Current evidence does not provide specific outcomes or safety data related to this device.
FDA Clearance Information
Pathway
510K
Number
K000845 ↗
Decision Date
April 10, 2000
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 10, 2000. It is manufactured by Jms and classified as a Class 2 device under product code FIE.
What It Is
The modification to the JMS A V Fistula Needle Set is designed for use in dialysis access procedures. It facilitates the connection between the patient's vascular system and the dialysis machine, ensuring efficient blood flow during treatment.
Clinical Applications
This device is commonly used in clinical settings for patients requiring hemodialysis. It is particularly relevant for those with arteriovenous fistulas, providing a reliable means of vascular access.
Evidence Summary
The available literature includes five studies, though none directly address the modification to the JMS A V Fistula Needle Set. The studies span various topics unrelated to this device, with no specific outcomes or safety data reported.
Reported Outcomes
Published studies report no specific efficacy findings related to the modification to the JMS A V Fistula Needle Set, as the provided evidence does not directly pertain to this device.
Safety Profile
Reported complications include no specific safety data for the modification to the JMS A V Fistula Needle Set, as the evidence provided does not address this device.
Evidence Limitations
The current evidence lacks direct studies on the modification to the JMS A V Fistula Needle Set, highlighting a need for targeted research. Existing studies do not provide relevant outcomes or safety data.
Frequently Asked Questions
What are the clinical indications for modification to JMS A V Fistula Needle Set?
The device is indicated for use in dialysis access, specifically for patients with arteriovenous fistulas.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported in the provided evidence for this device.
What complications have been reported?
The provided evidence does not report any complications specific to this device.
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.