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

    LAKE REGION HYDROPHILIC GUIDEWIRE

    K Number: K040825 · Decision May 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    42
    Review Days
    48

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    Basic Information

    Device Name
    LAKE REGION HYDROPHILIC GUIDEWIRE
    K Number
    K040825
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lake Region Mfg., Inc.
    Date Received
    March 30, 2004
    Decision Date
    May 17, 2004
    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 Lake Region Mfg., Inc.

    K Number Device Name
    K092965 TRAILRUNNER GUIDEWIRES
    K082922 FREEWAY AND RAILRUNNER GUIDEWIRES
    K081708 TAXI ENDOSCOPIC GUIDEWIRE
    K080144 MANDREL GUIDEWIRES OR M-WIRES
    K073655 PEGASUS STEERABLE (PTCA) GUIDEWIRE
    K060454 TITAN GUIDEWIRE
    K052347 TITAN STEERABLE (PTCA) GUIDEWIRE
    K042338 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
    K041624 PTCA STEERABLE HYDROPHILIC GUIDEWIRE
    K033758 HYDROPHILIC GUIDEWIRE
    Search all 42 clearances from Lake Region Mfg., Inc. →