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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K110845
Device Name IMPELLA CONTROLLER WITH FLOW CONTROL
Applicant
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact ROBERT STEWART
Correspondent
Abiomed, Inc.
22 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact ROBERT STEWART
Regulation Number870.4360
Classification Product Code
KFM  
Subsequent Product Code
DWA  
Date Received03/28/2011
Decision Date 04/27/2011
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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