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

    D2 HEMOSTANTIC DRESSING

    K Number: K140757 · Decision Jul 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    D2 HEMOSTANTIC DRESSING
    K Number
    K140757
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Z-Medica, LLC
    Date Received
    March 26, 2014
    Decision Date
    July 17, 2014
    Product Code
    QSY
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Z-Medica, LLC

    K Number Device Name
    K220971 QuikClot Control+ Hemostatic Dressing
    K200167 QuikClot Control+
    K181641 QuikClot Radial
    DEN160012 D2 Dressing
    K123387 QUIKCLOT HEMOSTATIC DRESSING