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510(k) Data Aggregation
K Number
K050814Device Name
ATRIUM ICAST COVERED STENTManufacturer
Date Cleared
2005-05-06
(36 days)
Product Code
Regulation Number
878.3720Type
SpecialReference & Predicate Devices
Why did this record match?
Device Name :
ATRIUM ICAST COVERED STENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Device Description
Not Found
AI/ML Overview
The provided FDA 510(k) summary only includes the regulatory approval status and indications for use of the Atrium iCAST Covered Stent. It does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence/machine learning device evaluation (such as sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot provide the requested information based on the given document.
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