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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 K122913
Device Name AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
Applicant
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact MARY E DONLIN
Correspondent
Medtronic, Inc.
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact MARY E DONLIN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received09/21/2012
Decision Date 10/19/2012
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
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