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

    GUIDEWIRES, VARIOUS TYPES

    K Number: K920884 · Decision Aug 19, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    230

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    Basic Information

    Device Name
    GUIDEWIRES, VARIOUS TYPES
    K Number
    K920884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acme-Monaco Corp.
    Date Received
    January 2, 1992
    Decision Date
    August 19, 1992
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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