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vitalflow set with balance biosurface
Medtronic
Summary: The VitalFlow Set with Balance BioSurface is an ablation device used for tumor treatment. It is typically utilized by oncologists and interventional radiologists in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K240880 ↗
Decision Date
September 12, 2024
Product Code
QJZ
Device Class
Class 2
Evidence
0 studies
The VitalFlow Set with Balance BioSurface was cleared through the FDA 510k pathway on September 12, 2024. Manufactured by Medtronic, it is classified as a Class 2 medical device.
What It Is
The VitalFlow Set with Balance BioSurface is a sophisticated medical device designed for the ablation of tumors. It utilizes advanced technology to deliver precise energy to targeted tissues, effectively destroying tumor cells while minimizing damage to surrounding healthy tissue. The Balance BioSurface technology enhances the device's efficacy and safety profile, making it a valuable tool in oncological procedures.
Clinical Applications
This device is commonly used in the treatment of various types of tumors, including liver, kidney, and lung tumors. It is primarily employed in interventional radiology and oncology departments, where minimally invasive procedures are performed. The device is suitable for adult patients who require tumor ablation as part of their cancer management plan.
Indications for Use
The FDA has cleared this device for the ablation of tumors, which means it is intended to treat patients with specific types of cancerous growths. It is particularly useful for patients who are not candidates for traditional surgical interventions.
Practical Considerations
The VitalFlow Set with Balance BioSurface is available in multiple sizes to accommodate different tumor sizes and locations. It is compatible with standard imaging guidance systems, which aids in precise placement and monitoring during procedures. Clinicians should be trained in the specific techniques required for optimal use of this device.
Frequently Asked Questions
What is VitalFlow Set with Balance BioSurface used for?
It is used for the ablation of tumors in patients with certain types of cancer.
What specialties typically use this device?
Oncologists and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is cleared for the ablation of tumors, particularly in patients who are not candidates for traditional surgery.
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.