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FDA 510(k) Application Details - K223898
Device Classification Name
More FDA Info for this Device
510(K) Number
K223898
Device Name
VitalFlowTM Centrifugal Pump
Applicant
Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.)
2555 Bishop Circle West
Dexter, MI 48130 US
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Contact
Martha Rumford
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2022
Decision Date
08/25/2023
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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