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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 K200612
Device Name R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
Applicant
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola,  IT 41037
Correspondent Contact Luigi Vecchi
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/09/2020
Decision Date 11/17/2020
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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