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FDA 510(k) Application Details - K223168
Device Classification Name
More FDA Info for this Device
510(K) Number
K223168
Device Name
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceÖ Biosurface
Applicant
Medtronic Inc.
8200 Coral Sea St. NE
Mounds View, MN 55112 US
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Contact
Anna Wetherille
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2022
Decision Date
04/19/2023
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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