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oncentra-visir
Nucletron
Summary: The Oncentra-Visir, developed by Nucletron, is a Class 2 medical device used in dialysis access procedures. It is primarily utilized by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K041719 ↗
Decision Date
July 22, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Oncentra-Visir was cleared through the FDA 510(k) pathway on July 22, 2004. Manufactured by Nucletron, it is classified as a Class 2 device under product code MUJ.
What It Is
The Oncentra-Visir is a medical device designed to assist in dialysis access procedures. It operates by providing precise visualization and guidance during the placement of dialysis catheters. This device is essential in ensuring accurate catheter placement, reducing complications, and improving patient outcomes.
Clinical Applications
The Oncentra-Visir is commonly used in nephrology and interventional radiology settings. It is particularly valuable in hospital environments where dialysis access is frequently performed. The device is used for patients requiring long-term dialysis, helping to establish and maintain vascular access efficiently.
Indications for Use
The FDA-cleared indications for the Oncentra-Visir involve its use in facilitating dialysis access. It is intended for patients who need reliable vascular access for ongoing dialysis treatments.
Practical Considerations
Clinicians should consider the compatibility of the Oncentra-Visir with existing dialysis equipment. Proper training in the use of this device is recommended to optimize its benefits and minimize potential complications during catheter placement.
Frequently Asked Questions
What is Oncentra-Visir used for?
The Oncentra-Visir is used to assist in the placement of dialysis catheters, ensuring accurate and efficient vascular access.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use the Oncentra-Visir in dialysis access procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating dialysis access, specifically for patients requiring long-term dialysis treatment.
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.