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Found 4 results
510(k) Data Aggregation
K Number
K011184Manufacturer
Date Cleared
2001-08-13
(117 days)
Product Code
Regulation Number
876.5010Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Device Name :
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K003997Manufacturer
Date Cleared
2001-01-24
(29 days)
Product Code
Regulation Number
876.5010Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Device Name :
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K003450Manufacturer
Date Cleared
2000-12-07
(30 days)
Product Code
Regulation Number
876.5010Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Device Name :
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K001648Device Name
INTRASTENT DOUBLESTRUT PARAMOUNTManufacturer
Date Cleared
2000-08-28
(90 days)
Product Code
Regulation Number
876.5010Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
INTRASTENT DOUBLESTRUT PARAMOUNT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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