BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    DUAL SHOT - CONTRAST DELIVERY SYSTEM

    K Number: K052633 · Decision Oct 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    8
    Review Days
    21

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    Basic Information

    Device Name
    DUAL SHOT - CONTRAST DELIVERY SYSTEM
    K Number
    K052633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nemoto Kyorindo Co., Ltd.
    Date Received
    September 26, 2005
    Decision Date
    October 17, 2005
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Nemoto Kyorindo Co., Ltd.

    K Number Device Name
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    K173450 PRESS DUO elite, PRESS DUO elite AG
    K133189 DUAL SHOT ALPHA 7
    K092896 REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS
    K091734 SONIC SHOT GX
    K071691 DUAL SHOT ALPHA
    K062168 CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA