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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 K142870
Device Name Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
Applicant
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Applicant Contact Michael Mahl
Correspondent
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Correspondent Contact Michaela Mahl
Regulation Number870.5150
Classification Product Code
QEW  
Date Received10/01/2014
Decision Date 05/26/2015
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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