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510(k) K122914

AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE by Medtronic, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2013
Date Received
September 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

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