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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 K250690
Device Name Penumbra System (Thunderbolt Aspiration Tubing)
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Applicant Contact Sindokht (Sisi) Soltanzadeh
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Correspondent Contact Sindokht (Sisi) Soltanzadeh
Regulation Number870.1250
Classification Product Code
NRY  
Date Received03/07/2025
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT05437055
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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