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

    Mikro-Cath Pressure Catheter

    K Number: K163376 · Decision Mar 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    1
    Review Days
    99

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    Basic Information

    Device Name
    Mikro-Cath Pressure Catheter
    K Number
    K163376
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Millar, Inc.
    Date Received
    December 1, 2016
    Decision Date
    March 10, 2017
    Product Code
    DXO
    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
    DXO Transducer, Pressure, Catheter Tip

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