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

    QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER

    K Number: K070010 · Decision Jan 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    8
    Review Days
    22

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    Basic Information

    Device Name
    QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
    K Number
    K070010
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Z-Medica Corporation
    Date Received
    January 3, 2007
    Decision Date
    January 25, 2007
    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 Corporation

    K Number Device Name
    K120782 INTERVENTIONAL HEMOSTATIC BANDAGE
    K090620 QUIKCLOT INTEVENTIONAL, MODEL P/N 182
    K080247 QUIKCLOT NOSEBLEED
    K072474 QUIKCLOT EX
    K061767 QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
    K051955 QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
    K050769 QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172