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K Number
K001734

Validate with FDA (Live)

Device Name
FOGARTY VALVULOTOME, MODEL 700091
Manufacturer
EDWARDS LIFESCIENCES, LLC.
Date Cleared
2001-03-26

(292 days)

Product Code
MGZ
Regulation Number
870.4885
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.4885 External vein stripper.

(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).