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

    Surfacer Inside-Out Access Catheter System

    K Number: DEN190038 · Decision Feb 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    179

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    Basic Information

    Device Name
    Surfacer Inside-Out Access Catheter System
    K Number
    DEN190038
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1342
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Bluegrass Vascular Technologies, Inc.
    Date Received
    August 15, 2019
    Decision Date
    February 10, 2020
    Product Code
    QJH
    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
    QJH Reverse Central Venous Recanalization System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QJH), ordered by most recent decision date.

    Surfacer Inside-Out Access Catheter System

    FDA 510(k)
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