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

    PTFE Guidewire

    K Number: K242824 · Decision Dec 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    16
    Review Days
    79

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    Basic Information

    Device Name
    PTFE Guidewire
    K Number
    K242824
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lake Region Medical
    Date Received
    September 18, 2024
    Decision Date
    December 6, 2024
    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 Medical

    K Number Device Name
    K253746 Enroute 0.014'' Transcarotid Guidewire
    K221575 Pre-Formed Blue
    K211741 Pre-Formed Extra Support Guidewire
    K160643 ENROUTE 0.014 Guidewire
    K151244 Pre-Formed Guidewire
    K140536 HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
    K142393 PREDICATE III GUIDEWIRE
    K142397 Predicate III Guidewire
    K140482 MANDREL GUIDEWIRE
    K133155 HYDROPHILIC COATED GUIDEWIRE
    Search all 16 clearances from Lake Region Medical →