K Number
K003500Device Name
REBSTOCK YASARGIL ANEURYSM CLIPManufacturer
Date Cleared
2001-05-30
(198 days)
Product Code
Regulation Number
882.5200Type
TraditionalPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).