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510(k) Data Aggregation
K Number
K141124Device Name
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFTManufacturer
Date Cleared
2014-05-30
(29 days)
Product Code
Regulation Number
870.3450Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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