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

    SUPERCATH5

    K Number: K140419 · Decision May 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    17
    Review Days
    83

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    Basic Information

    Device Name
    SUPERCATH5
    K Number
    K140419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Togo Medikit Co., Ltd.
    Date Received
    February 18, 2014
    Decision Date
    May 12, 2014
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Togo Medikit Co., Ltd.

    K Number Device Name
    K241230 Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
    K200379 Super Sheath
    K190001 Supercath 5
    K172496 SUPERCATH 5 (26G)
    K160592 SUPERCATH 6
    K141070 SUPER SHEATH
    K121504 SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
    K112290 SUPERCATH Z3V
    K093546 SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
    K081953 SUPERCATH 5
    Search all 17 clearances from Togo Medikit Co., Ltd. →