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510(k) Data Aggregation
K Number
K003452Manufacturer
Date Cleared
2000-12-07
(30 days)
Product Code
Regulation Number
870.1220Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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