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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 K000274
Device Name EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
Applicant
Medtronic Cardiac Surgical Products
620 Watson SW
Grand Rapids,  MI  49504
Applicant Contact JAMES BALUN
Correspondent
Medtronic Cardiac Surgical Products
620 Watson SW
Grand Rapids,  MI  49504
Correspondent Contact JAMES BALUN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/31/2000
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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