Home / 510(k) Clearances / K162958

510(k) K162958

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge by Medtronic, Inc. — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2017
Date Received
October 24, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat-Exchanger, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4240
Review Panel
CV
Submission Type

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