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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 K242503
Device Name Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
Applicant
Eurosets Srl
Strada Statale 12, N°143
Medolla,  IT 41036
Applicant Contact Katia Vescovini
Correspondent
Accurate Consultants, Inc.
3234 Ibis St.
San Diego,  CA  92103
Correspondent Contact Sebastian Feye
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTN   DTR  
Date Received08/22/2024
Decision Date 11/24/2025
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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