BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

    K Number: K242503 · Decision Nov 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    6
    Review Days
    459

    Basic Information

    Device Name
    Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
    K Number
    K242503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurosets S.R.L
    Date Received
    August 22, 2024
    Decision Date
    November 24, 2025
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Eurosets S.R.L

    K Number Device Name
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    K202206 AMG PMP Pediatric
    K141492 ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
    K102109 ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012