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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, blood, cardiopulmonary bypass, non-roller type
510(k) Number K190650
Device Name Revolution Centrifugal Blood Pump
Applicant
SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
LivaNova USA, Inc.
14401 West 65th Way
Arvada,  CO  80004
Correspondent Contact Scott Light
Regulation Number870.4360
Classification Product Code
KFM  
Date Received03/13/2019
Decision Date 08/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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