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

    BARD PTFE (TEFLON) COATED GUIDE WIRES

    K Number: K082094 · Decision Dec 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    3
    Review Days
    146

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    Basic Information

    Device Name
    BARD PTFE (TEFLON) COATED GUIDE WIRES
    K Number
    K082094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard Inc., Bard Electrophysiology Division
    Date Received
    July 24, 2008
    Decision Date
    December 17, 2008
    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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    Other Clearances by C.R. Bard Inc., Bard Electrophysiology Division

    K Number Device Name
    K113811 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
    K101331 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE