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needle set a-v fistula
Medical Disposables Intl.
Summary: The needle set a-v fistula is used for vascular access in hemodialysis. It is primarily used to facilitate efficient blood flow during dialysis sessions. Key evidence highlights the importance of early detection of access dysfunction.
FDA Clearance Information
Pathway
510K
Number
K770699 ↗
Decision Date
June 14, 1977
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The needle set a-v fistula was cleared by the FDA via the 510(k) pathway on June 14, 1977. It is manufactured by Medical Disposables Intl. and classified as a Class 2 device.
What It Is
The needle set a-v fistula is a medical device designed for creating vascular access in patients undergoing hemodialysis. It is intended to facilitate the connection between the patient's circulatory system and the dialysis machine.
Clinical Applications
This device is commonly used in clinical settings for patients requiring regular hemodialysis. It is essential for establishing and maintaining a reliable vascular access point to ensure effective dialysis treatment.
Evidence Summary
The literature includes 15 studies, ranging from 2015 to 2024, covering various aspects of hemodialysis access. These studies include prospective cohorts, RCTs, and case series, focusing on access dysfunction and needle-related complications.
Reported Outcomes
Published studies report that early detection of arteriovenous access dysfunction is crucial for maintaining vascular access patency. The use of deep learning models has shown promise in predicting access malfunctions. Additionally, needle-related complications are a significant concern, impacting the incidence of access issues.
Safety Profile
Reported complications include needle-related injuries during cannulation, which can lead to access dysfunction. Venous needle dislodgement is another potential complication, posing a risk during hemodialysis sessions.
Evidence Limitations
The evidence highlights gaps in the understanding of needle-related complications and their prevention. Further research is needed to optimize cannulation techniques and improve early detection methods for access dysfunction.
Frequently Asked Questions
What are the clinical indications for needle set a-v fistula?
The needle set a-v fistula is indicated for use in establishing vascular access for hemodialysis in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies have reported the importance of early detection of access dysfunction and the potential of deep learning models in predicting access issues.
What complications have been reported?
Safety data indicate needle-related injuries and venous needle dislodgement as notable complications during hemodialysis.
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.