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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 K251949
Device Name INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Applicant Contact Deanna Kimlinger
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Correspondent Contact Deanna Kimlinger
Regulation Number870.5150
Classification Product Code
QEW  
Date Received06/25/2025
Decision Date 02/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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