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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K251014
Device Name APRO 45 Catheter
Applicant
Alembic, LLC
627 National Ave.
Mountain View,  CA  94043
Applicant Contact Stina Almaleh
Correspondent
Alembic, LLC
627 National Ave.
Mountain View,  CA  94043
Correspondent Contact Stina Almaleh
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received04/02/2025
Decision Date 05/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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