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

    MICROCATHETER

    K Number: K112124 · Decision Aug 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    35
    Review Days
    25

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    Basic Information

    Device Name
    MICROCATHETER
    K Number
    K112124
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navilyst Medical, Inc.
    Date Received
    July 25, 2011
    Decision Date
    August 19, 2011
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Navilyst Medical, Inc.

    K Number Device Name
    K163452 PICC Maximal Barrier Nursing Kit
    K161866 BioFlo Midline Catheter
    K151239 NMI DUAL PORT II
    K153228 NMI Port, NMI Port II
    K152409 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
    K152069 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
    K150407 BioFlo Midline Catheter
    K150527 Xcela Power Injectable PICC
    K150448 NMI PICC III and NMI PICC IV
    K142616 PICC Maximal Barrier Nursing Kit
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