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model 90421 flexport interface
Spacelabs
Summary: The Model 90421 Flexport Interface by Spacelabs is an FDA-cleared device used primarily in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K903702 ↗
Decision Date
October 19, 1990
Product Code
DQA
Device Class
Class 2
Evidence
0 studies
The Model 90421 Flexport Interface was cleared through the FDA 510(k) pathway on October 19, 1990. Manufactured by Spacelabs, it is classified as a Class 2 medical device under product code DQA.
What It Is
The Model 90421 Flexport Interface is a medical device designed to facilitate the ablation of tumors. It acts as an interface in ablation procedures, providing a connection between the ablation device and monitoring systems. This interface ensures accurate delivery of ablation energy and real-time monitoring of the procedure, enhancing the safety and efficacy of tumor ablation treatments.
Clinical Applications
This device is commonly used in oncology and interventional radiology for the ablation of various types of tumors, including liver, kidney, and lung tumors. It is typically employed in hospital settings where precise tumor ablation is required. The device is suitable for adult patients undergoing minimally invasive procedures to treat malignant or benign tumors.
Indications for Use
The FDA indications suggest that the Model 90421 Flexport Interface is intended for use in procedures involving the ablation of tumors. This includes patients with solid tumors that are accessible for minimally invasive ablation techniques.
Practical Considerations
Clinicians should ensure compatibility with existing ablation systems and verify the appropriate sizing for the specific procedure. The device should be used by trained professionals familiar with tumor ablation techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the Model 90421 Flexport Interface used for?
It is used for facilitating tumor ablation procedures by connecting ablation devices to monitoring systems.
What specialties typically use this device?
Oncology and interventional radiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, particularly for solid tumors accessible via 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.