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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K222358
Device Name Indigo Aspiration System - Lightning Flash
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  95132
Applicant Contact Deanna Kimlinger
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  95132
Correspondent Contact Deanna Kimlinger
Regulation Number870.5150
Classification Product Code
QEW  
Date Received08/04/2022
Decision Date 12/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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