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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 K141951
Device Name DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact KEVIN T LAM
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact KEVIN T LAM
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/18/2014
Decision Date 08/15/2014
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
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