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510(k) K061369

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 by Cardiacassist, Inc. — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2006
Date Received
May 17, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Pump Speed, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4380
Review Panel
CV
Submission Type

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