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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 K022272
Device Name MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
Applicant
Medtronic Cardiac Surgical Products
620 Watson St. SW
Grad Rapids,  MI  49504
Applicant Contact ROGER BRINK
Correspondent
Medtronic Cardiac Surgical Products
620 Watson St. SW
Grad Rapids,  MI  49504
Correspondent Contact ROGER BRINK
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/15/2002
Decision Date 01/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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