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FDA 510(k) Application Details - K182586
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K182586
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
Medtronic, Inc.
8200 Coral Street NE
Mounds View, MN 55125 US
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Contact
Linda L. Julia Davila
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Regulation Number
870.4210
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Classification Product Code
DWF
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More FDA Info for this Product Code
Date Received
09/20/2018
Decision Date
10/19/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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