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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood pump for ecmo, long-term (> 6 hours) use
510(k) Number K222038
Device Name CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
Applicant
Abbott (formerly Thoratec Corporation)
6035 Stoneridge Drive
Pleasanton,  CA  94588
Applicant Contact Meera Mehta
Correspondent
Abbott (formerly Thoratec Corporation)
6035 Stoneridge Drive
Pleasanton,  CA  94588
Correspondent Contact Meera Mehta
Regulation Number870.4100
Classification Product Code
QNR  
Date Received07/11/2022
Decision Date 12/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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