BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Micro Catheter and Guidewire System

    K Number: K212719 · Decision Apr 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    227

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    Basic Information

    Device Name
    Micro Catheter and Guidewire System
    K Number
    K212719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Hengrui Hongyuan Medical Co., Ltd.
    Date Received
    August 27, 2021
    Decision Date
    April 11, 2022
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

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