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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 K180448
Device Name INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
Applicant
Sorin Group Italia S.r.l
86, Via Statale 12 Nord
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 Received02/13/2018
Decision Date 03/15/2018
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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