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510(k) K153143

Capiox Advance Hardshell Reservoir by Terumo Cardiovascular Systems Corporation — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2015
Date Received
October 30, 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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