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510(k) K131964

BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE by Medtronic, Inc. — Product Code DWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2013
Date Received
June 27, 2013
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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