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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 K210323
Device Name Indigo Aspiration System - Lightning Aspiration Tubing
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94501
Applicant Contact Micaela Victoria
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94501
Correspondent Contact Micaela Victoria
Regulation Number870.5150
Classification Product Code
QEW  
Date Received02/04/2021
Decision Date 02/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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