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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 K031827
Device Name ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
Applicant
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Applicant Contact PREETI JAIN
Correspondent
Medtronic Perfusion Systems
7611 Northland Dr.
Minneapolis,  MN  55038
Correspondent Contact PREETI JAIN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received06/13/2003
Decision Date 07/02/2003
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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