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510(k) K240190

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated by Medtronic — Product Code DTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2024
Date Received
January 24, 2024
Clearance Type
Special
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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