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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 K150422
Device Name EOPA 3D Arterial Cannula
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact Chelsea L Pioske
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact Chelsea L Pioske
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/19/2015
Decision Date 03/20/2015
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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