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exel a-v fistula set
Exel Intl.
Summary: The Exel A-V Fistula Set is a medical device used to establish vascular access for hemodialysis. It is primarily used by nephrologists and dialysis nurses in patients requiring long-term dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K903945 ↗
Decision Date
November 20, 1990
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Exel A-V Fistula Set was cleared through the FDA 510(k) pathway on November 20, 1990. Manufactured by Exel Intl., it is classified as a Class 2 device under product code FIE.
What It Is
The Exel A-V Fistula Set is designed to facilitate the creation of an arteriovenous fistula, which is a connection between an artery and a vein. This connection provides a durable and reliable access point for hemodialysis, allowing for efficient blood flow during treatment. The set typically includes needles, tubing, and connectors necessary for establishing and maintaining the fistula.
Clinical Applications
This device is commonly used in nephrology and dialysis centers to provide vascular access for patients undergoing regular hemodialysis. It is particularly important for patients with chronic kidney disease who require long-term dialysis. The device is used in both hospital and outpatient settings, primarily by nephrologists and dialysis nurses.
Indications for Use
The Exel A-V Fistula Set is indicated for patients who need reliable vascular access for hemodialysis. It is suitable for individuals with end-stage renal disease or chronic kidney disease who require regular dialysis sessions.
Practical Considerations
When using the Exel A-V Fistula Set, clinicians should consider the appropriate needle size and tubing length based on the patient's anatomy and dialysis needs. Compatibility with existing dialysis equipment should be verified to ensure seamless integration into the treatment protocol.
Frequently Asked Questions
What is the Exel A-V Fistula Set used for?
The Exel A-V Fistula Set is used to establish vascular access for hemodialysis in patients requiring long-term dialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in nephrology and dialysis settings.
What are the FDA-cleared indications?
The device is indicated for creating vascular access for hemodialysis in patients with chronic kidney disease or end-stage renal disease.
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.