BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor

    K Number: K180574 · Decision Aug 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    165

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    Basic Information

    Device Name
    Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor
    K Number
    K180574
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J & J Solutions, Inc. D/B/A/ Corvida Medical
    Date Received
    March 5, 2018
    Decision Date
    August 17, 2018
    Product Code
    ONB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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    Other Clearances by J & J Solutions, Inc. D/B/A/ Corvida Medical

    K Number Device Name
    K150486 Halo