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

    VASSALLO GT

    K Number: K203533 · Decision Apr 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    140

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    Basic Information

    Device Name
    VASSALLO GT
    K Number
    K203533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Filmecc Co., Ltd.
    Date Received
    December 2, 2020
    Decision Date
    April 21, 2021
    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 Filmecc Co., Ltd.

    K Number Device Name
    K223432 Vassallo GT 018 Hybrid
    K222631 VASSALLO GT EXT
    K213949 VASSALLO GT 018 Floppy
    K203529 VASSALLO GT Hybrid