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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Mechanical Thrombectomy With Aspiration
510(k) Number K163618
Device Name INDIGO Aspiration System
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Applicant Contact RICHARD KIMURA
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Correspondent Contact RICHARD KIMURA
Regulation Number870.5150
Classification Product Code
QEX  
Subsequent Product Code
QEW  
Date Received12/22/2016
Decision Date 05/24/2017
Decision SE - With Limitations (SESU)
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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