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510(k) Data Aggregation
K Number
K001063Device Name
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7Manufacturer
Date Cleared
2000-07-07
(95 days)
Product Code
Regulation Number
870.1240Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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