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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K240584
Device Name XTRA Autotransfusion System (with XTRA Bowl sets)
Applicant
Sorin group Italia S.r.l.
Via Statale 12 Nord, 86
Mirandola (Modena),  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Sorin group Italia S.r.l.
Via Statale 12 Nord, 86
Mirandola (Modena),  IT 41037
Correspondent Contact Luigi Vecchi
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/01/2024
Decision Date 04/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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