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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K251015
Device Name APRO 45 Catheter and Alembic Aspiration Tubing
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
NRY  
Date Received04/02/2025
Decision Date 04/30/2025
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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