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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K242092
Device Name MICRO Arterial Filters
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 Number870.4260
Classification Product Code
DTM  
Date Received07/17/2024
Decision Date 11/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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