📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to facilitate vascular access for dialysis procedures.
- Used to assist with placement of dialysis catheters.
Clinical Applications
- Assisting clinicians during dialysis catheter placement.
- Supporting establishment of vascular access for patients receiving ongoing dialysis.
- Providing visualization or procedural guidance during dialysis-access procedures.
Practical Considerations
- Confirm compatibility with the dialysis-access equipment and imaging systems used at the facility.
- Use should follow the manufacturer's instructions, institutional protocols, and appropriate clinician training.
- The available record does not specify device dimensions, catheter sizes, MRI safety, or MRI-conditional labeling; consult the current manufacturer documentation before use in or near an MRI environment.
- Assess the patient and planned access site for standard dialysis-access contraindications, including infection, thrombosis, or unsuitable vascular anatomy.
- The device is intended to support access procedures; it does not replace clinical assessment, imaging guidance, or management of catheter-related complications.
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.