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explorer
Mansfield Scientific
Summary: The explorer by Mansfield Scientific is a Class 3 medical device cleared by the FDA for use in clinical settings. It is primarily used in the context of IVC filters. Key evidence includes studies on non-invasive quantification techniques.
FDA Clearance Information
Pathway
510K
Number
K853850 ↗
Decision Date
December 4, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The explorer was cleared by the FDA through the 510(k) pathway on December 4, 1985. It is manufactured by Mansfield Scientific and classified as a Class 3 device.
What It Is
The explorer is a medical device used in the context of IVC filters. It is designed to assist clinicians in the placement and management of these filters, which are used to prevent pulmonary embolism by capturing blood clots.
Clinical Applications
The explorer is commonly used in interventional radiology and vascular surgery settings. It aids in the placement of IVC filters in patients at risk of pulmonary embolism, particularly those who cannot be managed with anticoagulation therapy alone.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs and prospective studies. The studies span from 2023 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report on the efficacy of the explorer in facilitating non-invasive quantification of brain amyloid burden and visual exploration of molecular models. However, specific outcomes related to IVC filter placement were not detailed in the provided evidence.
Safety Profile
Reported complications include potential challenges in visualization and manipulation of molecular models without specialized tools. No specific safety data related to IVC filter placement was provided in the evidence.
Evidence Limitations
The evidence lacks specific data on the clinical outcomes of IVC filter placement using the explorer. Further research is needed to evaluate its efficacy and safety in this context, as well as to explore potential complications.
Frequently Asked Questions
What are the clinical indications for explorer?
The explorer is indicated for use in the placement and management of IVC filters to prevent pulmonary embolism.
What outcomes have been reported in clinical studies?
Studies have reported on the device's role in non-invasive quantification techniques and molecular model visualization, but specific outcomes for IVC filter placement are not detailed.
What complications have been reported?
Reported complications include visualization challenges in molecular modeling, with no specific safety data on IVC filter placement provided.
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.