BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MRWire Guide Wire

    K Number: K160594 · Decision Nov 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    3
    Review Days
    266

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    Basic Information

    Device Name
    MRWire Guide Wire
    K Number
    K160594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano4imaging GmbH
    Date Received
    March 1, 2016
    Decision Date
    November 22, 2016
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Nano4imaging GmbH

    K Number Device Name
    K253262 EmeryGlide™ (EG18008901)
    K173423 MR Wire Guide Wire Straight, MR Wire Guide Wire Angled