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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 K162215
Device Name Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
Applicant
Sorin Group Italia S.R.L.
86, Via Statale 12 Nord
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Parexel Consulting, LLC
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact SCOTT LIGHT
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/08/2016
Decision Date 06/16/2017
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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