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variseed v10
Varian Medical Systems
Summary: The Variseed V10 is a medical device used in dialysis access procedures. It is primarily utilized by nephrologists and vascular surgeons to facilitate efficient dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K232400 ↗
Decision Date
September 8, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Variseed V10 was cleared through the FDA 510k pathway on September 8, 2023. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The Variseed V10 is a specialized device designed to assist in creating and maintaining vascular access for dialysis patients. It functions by ensuring reliable and durable access to the bloodstream, which is crucial for effective dialysis treatment. The device is engineered to meet the specific needs of patients requiring long-term dialysis, providing a stable and efficient conduit for blood flow.
Clinical Applications
The Variseed V10 is commonly used in clinical settings such as hospitals and dialysis centers. It is utilized by nephrologists and vascular surgeons during procedures to establish or maintain vascular access in patients with chronic kidney disease. This device is particularly beneficial for patients who require regular dialysis, as it helps to minimize complications and improve the overall efficiency of the dialysis process.
Indications for Use
The FDA indications for the Variseed V10 focus on its use in dialysis access procedures. It is intended for patients who need reliable vascular access for ongoing dialysis treatment, typically those with chronic kidney disease or end-stage renal disease.
Practical Considerations
When using the Variseed V10, clinicians should consider the appropriate sizing to match the patient's vascular anatomy. Compatibility with existing dialysis equipment is generally high, but it's important to verify specific technical requirements. Proper technique during insertion and maintenance is crucial to ensure optimal device performance and patient outcomes.
Frequently Asked Questions
What is Variseed V10 used for?
The Variseed V10 is used for creating and maintaining vascular access in patients undergoing dialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use the Variseed V10 in dialysis access procedures.
What are the FDA-cleared indications?
The Variseed V10 is indicated for use in establishing and maintaining vascular access for dialysis patients, particularly those with chronic kidney 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.