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

    THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT

    K Number: K050511 · Decision Apr 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    103
    Review Days
    44

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    Basic Information

    Device Name
    THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
    K Number
    K050511
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Solutions, Inc.
    Date Received
    March 1, 2005
    Decision Date
    April 14, 2005
    Product Code
    QSX
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics

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    D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505

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    D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005

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    THROMBIX PATCH THROMBIN HEMOSTASIS PATCH

    FDA 510(k)
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