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510(k) K110845

IMPELLA CONTROLLER WITH FLOW CONTROL by Abiomed, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2011
Date Received
March 28, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

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