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a v fistula needle set
Cordis
Summary: The a v fistula needle set by Cordis is used for vascular access in hemodialysis. Key evidence highlights its role in reducing needle-related complications.
FDA Clearance Information
Pathway
510K
Number
K782021 ↗
Decision Date
March 21, 1979
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The a v fistula needle set was cleared by the FDA via the 510(k) pathway on March 21, 1979. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The a v fistula needle set is a medical device used for creating vascular access in patients undergoing hemodialysis. It facilitates the connection between the patient's circulatory system and the dialysis machine.
Clinical Applications
Commonly used in hemodialysis centers, this device is essential for patients requiring regular dialysis treatment. It is particularly used in scenarios where arteriovenous fistulas are the preferred access method.
Evidence Summary
The literature includes 15 studies ranging from 2015 to 2024, encompassing various study types such as RCTs and prospective cohorts. These studies focus on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the a v fistula needle set is effective in maintaining vascular access patency and reducing the incidence of needle-related complications. It is associated with improved outcomes in hemodialysis access management.
Safety Profile
Reported complications include needle-related injuries and venous needle dislodgement, which can lead to significant clinical issues. However, the device is generally considered safe when used according to guidelines.
Evidence Limitations
Current evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to standardize outcomes and improve safety protocols.
Frequently Asked Questions
What are the clinical indications for a v fistula needle set?
The device is indicated for vascular access in hemodialysis patients, particularly those with arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies have reported effective maintenance of vascular access and reduced needle-related complications.
What complications have been reported?
Safety data indicate potential for needle-related injuries and venous needle dislodgement.
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.