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K Number
K010908
Device Name
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
Manufacturer
MEDICON, E.G.
Date Cleared
2001-08-01

(128 days)

Product Code
HCH
Regulation Number
882.5200
Type
Traditional
Panel
NE
Reference & 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).