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K Number
K003719

Validate with FDA (Live)

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
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K032105
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).