MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface (Bridge System)

Heat-exchanger, Cardiopulmonary Bypass

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Myotherm Xp Cardioplegia Delivery System With Cortiva Bioactive Surface, Myotherm Xp Cardioplegia Delivery System With Cortiva Bioactive Surface (bridge System).

Pre-market Notification Details

Device IDK162774
510k NumberK162774
Device Name:MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface (Bridge System)
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant Medtronic, Inc. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactHarsh Dharamshi
CorrespondentHarsh Dharamshi
Medtronic, Inc. 8200 Coral Sea Street NE Mounts View,  MN  55112
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2016-10-03
Decision Date2017-02-10
Summary:summary

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