K Number
DEN240048Device Name
Spur Peripheral Retrievable Stent SystemManufacturer
Date Cleared
2025-05-29
(251 days)
Product Code
Regulation Number
870.5110Type
DirectPanel
CVReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A