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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K190690
Device Name INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
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 Number870.4350
Classification Product Code
DTZ  
Date Received03/18/2019
Decision Date 04/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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