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FDA 510(k) Application Details - K221373
Device Classification Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K221373
Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant
LivaNova Deutschland GmbH
Lindberghstr. 25
Munich 80939 DE
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Contact
Julia E. Leslie
Other 510(k) Applications for this Contact
Regulation Number
870.4220
More FDA Info for this Regulation Number
Classification Product Code
DTQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/12/2022
Decision Date
03/09/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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