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

    THE NINER NITINOL GUIDEWIRE

    K Number: K952860 · Decision Dec 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    18
    Review Days
    174

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    Basic Information

    Device Name
    THE NINER NITINOL GUIDEWIRE
    K Number
    K952860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microvena Corp.
    Date Received
    June 22, 1995
    Decision Date
    December 13, 1995
    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 Microvena Corp.

    K Number Device Name
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    K970668 THE AMPLANTZ GOOSE NECK MICROSNARE
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    K971984 AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
    K954642 HYDRO-SELECT GUIDEWIRE
    K954205 THE AMPLATZ THROMBECTOMY DEVICE
    K955304 CRICKET
    K946356 M-PATH NITINOL GUIDEWIRE
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