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K Number
K003070
Device Name
ETHIBOND EXCEL VALVE LOOP SUTURE
Manufacturer
ETHICON, INC.
Date Cleared
2000-11-07

(36 days)

Product Code
DXZ
Regulation Number
870.3470
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K053492
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).