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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K251783
Device Name Inspire HCR and HCR DUAL cardiotomy reservoirs
Applicant
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola (Modena),  IT 41037
Applicant Contact Martina Carlini
Correspondent
Sorin Group Italia S.R.L.
Via Statale 12 Nord, 86
Mirandola (Modena),  IT 41037
Correspondent Contact Martina Carlini
Regulation Number870.4400
Classification Product Code
DTN  
Date Received06/11/2025
Decision Date 12/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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