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510(k) Data Aggregation
K Number
K003551Manufacturer
Date Cleared
2001-07-11
(236 days)
Product Code
Regulation Number
870.4400Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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