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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 K262392
Device Name APRO 35 Swift 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 Received07/14/2026
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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