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connector components with balance biosurface
Medtronic
Summary: The connector components with balance biosurface by Medtronic are used in tumor ablation procedures. They are typically utilized by interventional radiologists and oncologists to treat tumors through minimally invasive techniques.
FDA Clearance Information
Pathway
510K
Number
K122811 ↗
Decision Date
October 12, 2012
Product Code
DTL
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 12, 2012. Manufactured by Medtronic, it is classified as a Class 2 device under product code DTL.
What It Is
The connector components with balance biosurface are specialized medical devices designed for use in tumor ablation procedures. They facilitate the connection and integration of ablation systems, ensuring effective energy transfer to target tissues. The balance biosurface technology aims to enhance the compatibility and performance of the device during procedures, optimizing treatment outcomes.
Clinical Applications
These devices are commonly used in interventional radiology and oncology settings for the ablation of tumors, particularly in the liver, lungs, and kidneys. They are employed in minimally invasive procedures where precise targeting and energy delivery are crucial. Patients with inoperable tumors or those who prefer less invasive treatment options are typical candidates for procedures involving this device.
Indications for Use
The FDA-cleared indications for this device include its use in tumor ablation procedures. It is specifically designed for patients with tumors that are suitable for ablation, allowing for targeted destruction of cancerous tissues.
Practical Considerations
When using these connector components, clinicians should ensure compatibility with existing ablation systems. The device's design supports various sizing options to accommodate different procedural needs. Proper technique and positioning are essential for optimal performance and patient outcomes.
Frequently Asked Questions
What is connector components with balance biosurface used for?
It is used for tumor ablation procedures, facilitating effective energy transfer to target tissues.
What specialties typically use this device?
Interventional radiologists and oncologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, targeting tumors that are suitable for such minimally invasive treatments.
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.