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510(k) K151110

Intersept Filtered Cardiotomy Reservoir by Medtronic, Inc. — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2015
Date Received
April 27, 2015
Clearance Type
Special
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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