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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 K061254
Device Name EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Applicant Contact RONALD W BENNETT
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Correspondent Contact RONALD W BENNETT
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/04/2006
Decision Date 06/23/2006
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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