Heater-Cooler System 3T

Controller, Temperature, Cardiopulmonary Bypass

LivaNova Deutschland GmbH

The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for Heater-cooler System 3t.

Pre-market Notification Details

Device IDK220635
510k NumberK220635
Device Name:Heater-Cooler System 3T
ClassificationController, Temperature, Cardiopulmonary Bypass
Applicant LivaNova Deutschland GmbH Lindbergh Strasse 25 Munchen,  DE 80939
ContactJulia E. Leslie
CorrespondentJulia E. Leslie
LivaNova Deutschland GmbH Lindbergh Strasse 25 Munchen,  DE 80939
Product CodeDWC  
CFR Regulation Number870.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-11-16

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