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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 K252917
Device Name ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
Applicant
Genesee Biomedical, Inc.
700 W. Mississippi Ave., Unit D-5
Denver,  CO  80223
Applicant Contact James Cross
Correspondent
Genesee Biomedical, Inc.
700 W. Mississippi Ave., Unit D-5
Denver,  CO  80223
Correspondent Contact James Cross
Regulation Number878.4300
Classification Product Code
PZX  
Date Received09/12/2025
Decision Date 05/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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