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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, Neurovasculature
510(k) Number K243297
Device Name APRO 70 Swift Catheter
Applicant
Alembic, LLC
627 National Ave.
Mountain View,  CA  94043
Applicant Contact Lisa Yen
Correspondent
Alembic, LLC
627 National Ave.
Mountain View,  CA  94043
Correspondent Contact Lisa Yen
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received10/18/2024
Decision Date 01/14/2025
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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