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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K253616
Device Name ProtekDilate Vascular Access Kit
Applicant
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola ( Modena),  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
LivaNova USA, Inc.
14401 W. 65th Way
Arvada,  CO  80004
Correspondent Contact Jennifer Houck
Regulation Number870.1310
Classification Product Code
DRE  
Date Received11/18/2025
Decision Date 12/19/2025
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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