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

    TEFLON COATED GUIDE WIRES & CATHETER

    K Number: K822586 · Decision Oct 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    21
    Review Days
    53

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    Basic Information

    Device Name
    TEFLON COATED GUIDE WIRES & CATHETER
    K Number
    K822586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Universal Medical Instrument Corp.
    Date Received
    August 26, 1982
    Decision Date
    October 18, 1982
    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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