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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 K192833
Device Name Indigo Aspiration System
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Applicant Contact Teri Nguyen
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Correspondent Contact Teri Nguyen
Regulation Number870.5150
Classification Product Code
QEW  
Date Received10/02/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03218566
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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