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510(k) K093801

IMPELLA CONTROLLER by Abiomed, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2010
Date Received
December 10, 2009
Clearance Type
Traditional
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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