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delta-a v fistula cannulation set
Amisco Trading
Summary: The delta-a v fistula cannulation set is used for vascular access in dialysis patients, primarily by nephrologists and dialysis nurses. It facilitates safe and effective cannulation of arteriovenous fistulas.
FDA Clearance Information
Pathway
510K
Number
K812621 ↗
Decision Date
September 24, 1981
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The delta-a v fistula cannulation set was cleared through the FDA 510(k) pathway on September 24, 1981. Manufactured by Amisco Trading, it is classified as a Class 2 device under product code FIE.
What It Is
The delta-a v fistula cannulation set is a medical device designed for the cannulation of arteriovenous fistulas, which are surgically created connections between an artery and a vein. This device is essential for patients undergoing hemodialysis, as it provides a reliable access point for blood withdrawal and return. The set typically includes needles and tubing designed to minimize trauma and optimize blood flow during dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is crucial for patients with chronic kidney disease who require regular hemodialysis. The set is used in procedures where establishing and maintaining vascular access is necessary, ensuring efficient and repeated access to the bloodstream.
Indications for Use
The delta-a v fistula cannulation set is indicated for use in patients who have an arteriovenous fistula for hemodialysis. It is specifically designed to facilitate the repeated access needed for dialysis treatments, ensuring effective blood flow and minimizing complications.
Practical Considerations
Clinicians should consider the size and type of needles included in the set to match patient-specific needs and fistula characteristics. Proper technique in cannulation is essential to prevent complications such as infiltration or hematoma. Compatibility with existing dialysis equipment should be verified.
Related Literature
The linked study investigated the impact of pre-operative forearm exercises on the maturation and blood flow of arteriovenous fistulas. Although the abstract is not available, such studies typically aim to enhance fistula development and functionality. Limitations may include small sample sizes or lack of long-term follow-up, affecting the generalizability of the findings.
Frequently Asked Questions
What is delta-a v fistula cannulation set used for?
It is used for the cannulation of arteriovenous fistulas in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses commonly use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients with arteriovenous fistulas for hemodialysis, facilitating repeated vascular access.
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.