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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 K262904
Device Name INDIGO® Aspiration System
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Applicant Contact Nikita Patel
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Correspondent Contact Nikita Patel
Regulation Number870.5150
Classification Product Code
QEW  
Date Received08/18/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT05003843
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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