BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI

    K Number: K923681 · Decision Jan 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI
    K Number
    K923681
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exonix Research Corp.
    Date Received
    July 22, 1992
    Decision Date
    January 21, 1993
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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