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

    D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015

    K Number: K083190 · Decision Nov 12, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    103
    Review Days
    14

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    Basic Information

    Device Name
    D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
    K Number
    K083190
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Solutions, Inc.
    Date Received
    October 29, 2008
    Decision Date
    November 12, 2008
    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

    Similar 510(k) Clearances

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    FDA Unclassified ·Unknown

    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

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    THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT

    FDA 510(k)
    FDA Unclassified ·Unknown
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    Other Clearances by Vascular Solutions, Inc.

    K Number Device Name
    K182232 Octane Mechanical Thrombectomy System
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    K180913 VSI Micro-Introducer Kit
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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
    K173266 Octane aspiration system
    K170544 Langston dual lumen catheter
    K171946 Gel-Bead
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