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K Number
K234125
Device Name
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
Manufacturer
AtriCure, Inc.
Date Cleared
2024-07-29

(214 days)

Product Code
PZX
Regulation Number
878.4300
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.