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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K191557
Device Name CentriMag Acute Circulatory Support System
Applicant
Thoratec Corporation (Now Part of Abbott)
6035 Stoneridge Dr.
Pleasanton,  CA  94588
Applicant Contact Lori Dondiego
Correspondent
Thoratec Corporation (Now Part of Abbott)
6035 Stoneridge Dr.
Pleasanton,  CA  94588
Correspondent Contact Lori Dondiego
Regulation Number870.4380
Classification Product Code
DWA  
Date Received06/12/2019
Decision Date 07/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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