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510(k) Data Aggregation
Device Name
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIEDManufacturer
Date Cleared
1996-11-15
(210 days)
Product Code
Regulation Number
870.3535Type
TraditionalPanel
CardiovascularAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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