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510(k) Data Aggregation
K Number
K010253Device Name
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101Manufacturer
Date Cleared
2002-03-19
(417 days)
Product Code
Regulation Number
870.1240Type
TraditionalPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
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Device Name :
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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