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

    THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT

    K Number: K070938 · Decision Aug 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    103
    Review Days
    124

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    Basic Information

    Device Name
    THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
    K Number
    K070938
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Solutions, Inc.
    Date Received
    April 4, 2007
    Decision Date
    August 6, 2007
    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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    THROMBIX PATCH THROMBIN HEMOSTASIS PATCH

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    Other Clearances by Vascular Solutions, Inc.

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    K180128 Warrior 14 guidewire
    K173891 Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
    K173532 Raider Guidewire
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