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

    SAFFRON NM GUIDING CATHETER

    K Number: K030715 · Decision Apr 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    SAFFRON NM GUIDING CATHETER
    K Number
    K030715
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neich Medical (Shenzhen) Company Limited
    Date Received
    March 7, 2003
    Decision Date
    April 24, 2003
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Neich Medical (Shenzhen) Company Limited

    K Number Device Name
    K032888 CREATION NM DIAGNOSTIC CATHETERS