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510(k) Data Aggregation
K Number
K003084Manufacturer
Date Cleared
2001-05-16
(225 days)
Product Code
Regulation Number
870.1330Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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