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FDA 510(k) Application Details - K143083
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K143083
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
MEDTRONIC, INC
8200 CORAL ST NE
MOUNDS VIEW, MN 55112 US
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Contact
BRUCE BACKLUND
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Regulation Number
870.4210
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Classification Product Code
DWF
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Date Received
10/27/2014
Decision Date
03/25/2015
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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