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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 K943934
Device Name AORTIC ARCH CANNULAS
Applicant
Sorin Group Italia S.R.L.
86, Via Statale 12 Nord
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Liva Nova Usa, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact Jennifer Houck
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/12/1994
Decision Date 06/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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