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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K182586
Device Name DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
Applicant
Medtronic, Inc.
8200 Coral Street NE
Mounds View,  MN  55125
Applicant Contact Linda L. Julia Davila
Correspondent
Medtronic, Inc.
8200 Coral Street NE
Mounds View,  MN  55125
Correspondent Contact Linda L. Julia Davila
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/20/2018
Decision Date 10/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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