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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 K261438
Device Name HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Applicant
Eurosets S.R.L
Strada Statale 12, N°143
Medolla,  IT 41036
Applicant Contact Katia Vescovini
Correspondent
Accurate Consultants, Inc.
4367 Narragansett Ave.
San Diego,  CA  92107
Correspondent Contact Sebastian Feye
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTN   DTR  
Date Received04/30/2026
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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