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FDA 510(k) Application Details - K110845
Device Classification Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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510(K) Number
K110845
Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant
ABIOMED, INC.
22 CHERRY HILL DR.
DANVERS, MA 01923 US
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Contact
ROBERT STEWART
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Regulation Number
870.4360
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Classification Product Code
KFM
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More FDA Info for this Product Code
Date Received
03/28/2011
Decision Date
04/27/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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