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

    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

    K Number: K131517 · Decision Aug 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
    K Number
    K131517
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medrad, Inc. / Bayer Medical Care, Inc.
    Date Received
    May 28, 2013
    Decision Date
    August 2, 2013
    Product Code
    FPK
    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
    FPK Tubing, Fluid Delivery

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