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eclipse helios option
Varian Medical Systems
Summary: The Eclipse Helios Option is a medical device used in dialysis access procedures. It is typically utilized by nephrologists and vascular surgeons to facilitate dialysis in patients with kidney failure.
FDA Clearance Information
Pathway
510K
Number
K021268 ↗
Decision Date
May 22, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Eclipse Helios Option was cleared through the FDA 510(k) pathway on May 22, 2002. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The Eclipse Helios Option is a specialized medical device designed to assist in creating and maintaining vascular access for dialysis patients. It works by providing a reliable means to connect dialysis equipment to the patient's blood vessels, ensuring efficient blood filtration. The device is engineered to meet the specific needs of dialysis procedures, offering durability and compatibility with standard dialysis equipment.
Clinical Applications
This device is commonly used in clinical settings where patients require regular dialysis, such as hospitals and outpatient dialysis centers. Nephrologists and vascular surgeons use it to establish and maintain vascular access in patients with chronic kidney disease. It is particularly crucial for patients who need long-term dialysis treatment, ensuring that the access point remains functional and reduces the risk of complications.
Indications for Use
The FDA-cleared indications for the Eclipse Helios Option involve its use in patients who require dialysis due to kidney failure. It is intended for creating and maintaining vascular access, which is essential for the dialysis process.
Practical Considerations
When using the Eclipse Helios Option, clinicians should consider the appropriate sizing to match the patient's vascular anatomy. The device is compatible with standard dialysis equipment, but proper technique in insertion and maintenance is crucial to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is Eclipse Helios Option used for?
The Eclipse Helios Option is used to create and maintain vascular access for patients undergoing dialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis procedures.
What are the FDA-cleared indications?
The device is indicated for use in creating and maintaining vascular access for dialysis in patients with kidney failure.
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.