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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K263319
Device Name ACHM30 AtriClip FLEX-Mini LAA Exclusion System
Applicant
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Applicant Contact Diane Sung
Correspondent
AtriCure, Inc.
7555 Innovation Way
Mason,  OH  45040
Correspondent Contact Diane Sung
Regulation Number878.4300
Classification Product Code
PZX  
Subsequent Product Code
FZX  
Date Received09/21/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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