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

    SAYA 86 Radial Access Guide Catheter

    K Number: K254178 · Decision May 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    84
    Review Days
    139

    Basic Information

    Device Name
    SAYA 86 Radial Access Guide Catheter
    K Number
    K254178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asahi Intecc Co., Ltd.
    Date Received
    December 23, 2025
    Decision Date
    May 11, 2026
    Product Code
    QJP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QJP Catheter, Percutaneous, Neurovasculature

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