K Number
K001734Device Name
FOGARTY VALVULOTOME, MODEL 700091Manufacturer
Date Cleared
2001-03-26
(292 days)
Product Code
Regulation Number
870.4885Type
TraditionalPanel
CVReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 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).