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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 K052372
Device Name MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
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 Received08/30/2005
Decision Date 09/22/2005
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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