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K Number
K003719
Device Name
VASCULAR ARCHITECTS PERISCOPE DEVICE
Manufacturer
VASCULAR ARCHITECTS, INC.
Date Cleared
2001-02-28

(86 days)

Product Code
DWX
Regulation Number
870.4875
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).