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

    SELECTIVA SB GUIDEWIRE

    K Number: K033321 · Decision Nov 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    252
    Registration Numbers
    253
    Same Product Code
    751
    Applicant Total
    7
    Review Days
    21

    Basic Information

    Device Name
    SELECTIVA SB GUIDEWIRE
    K Number
    K033321
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NEO METRICS, INC.
    Date Received
    October 15, 2003
    Decision Date
    November 5, 2003
    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 NEO METRICS, INC.

    K Number Device Name
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    K040786 VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
    K031652 VASCUPUNCTURE PICC GUIDEWIRE
    K012861 VASCUPUNCTURE ACCESS WIRE
    K013024 SELECTIVA GUIDEWIRE