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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K253652
Device Name Genie MAX Large Bore Introducer Sheath
Applicant
Cultiv8 1, LLC
3405 Annapolis Ln N
Suite 200
Plymouth,  MN  55447
Applicant Contact Robert Atkinson
Correspondent
Cultiv8 1, LLC
3405 Annapolis Ln N
Suite 200
Plymouth,  MN  55447
Correspondent Contact Robert Atkinson
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/20/2025
Decision Date 01/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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