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medrad flex interface device
Medrad
Summary: The Medrad Flex Interface Device is used in tumor ablation procedures, primarily by interventional radiologists. It facilitates the connection between ablation equipment and the patient.
FDA Clearance Information
Pathway
510K
Number
K971380 ↗
Decision Date
July 3, 1997
Product Code
LNH
Device Class
Class 2
Evidence
0 studies
The Medrad Flex Interface Device was cleared via the FDA 510k pathway on July 3, 1997, by Medrad. It is classified as a Class 2 device under product code LNH.
What It Is
The Medrad Flex Interface Device is a medical device designed to interface with ablation systems used for tumor treatment. It serves as a conduit, ensuring proper connection and communication between the ablation equipment and the patient. This device is crucial in maintaining the integrity of the procedure by providing a stable and reliable interface.
Clinical Applications
Commonly used in interventional radiology, the Medrad Flex Interface Device is employed during procedures aimed at ablating tumors. It is particularly useful in settings where precise and controlled ablation is necessary, such as in oncology departments. The device is suitable for use in both inpatient and outpatient settings, catering to adult and geriatric populations with tumor-related conditions.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in procedures that require tumor ablation. It is suitable for patients with tumors that are accessible via minimally invasive techniques.
Practical Considerations
The Medrad Flex Interface Device is typically compatible with a range of ablation systems. Clinicians should ensure proper sizing and connection to avoid procedural interruptions. Familiarity with the device's setup and operation is crucial for optimal performance.
Frequently Asked Questions
What is the Medrad Flex Interface Device used for?
It is used to facilitate the connection between ablation systems and patients during tumor ablation procedures.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device during tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, particularly for patients with tumors accessible through minimally invasive techniques.
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.