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510(k) Data Aggregation

    K Number
    K073664
    Device Name
    FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
    Manufacturer
    INJECTIMED, INC.
    Date Cleared
    2008-08-08

    (226 days)

    Product Code
    MDM
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    INJECTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
    Device Description
    A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.
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    K Number
    K040029
    Device Name
    SAFETYNET GUIDEWIRE INTRODUCER
    Manufacturer
    INJECTIMED, INC.
    Date Cleared
    2004-04-05

    (88 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    INJECTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Frontline Medical Products SafetyNet™ Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.
    Device Description
    The Frontline Medical Products SafetyNet™ Guidewire Introducer is a sterile, single-use disposable device, available in gauge sizes from 18G to 21G and usable lengths up to 2.75." The 18G product is compatible with guidewires up to 0.038" diameter. the 21G is compatible with guidewires up to 0.021" diameter. The product consists of a conventional hypodermic needle-type guidewire introducer with molded plastic luer hub, modified to accept additional components to provide a needle protection feature. The additional components create a spring-loaded molded plastic safety guard assembly that is stored within a semi-rigid housing prior to deployment. After the needle is placed in the blood vessel and the quidewire is introduced, the user deploys the safety guard with a one-handed technique by squeezing two opposing tabs on the housing. This causes the safety quard to move forward to the end of the needle. when a hinged trap within the safety quard drops over the needle point, and is held in place by the spring. The safety guard is restrained from moving off the end of the needle by means of a sliding rigid bushing contained within the safety guard, that stops when reaching a small deformation (bump) that has been created on the distal end of the needle cannula during manufacturing. The used product is then disposed of in a sharps container according to routine policies and procedures. The deployed safety guard provides a reduced risk of accidental needlestick injury. The product will be packaged as single sterile units, or may be provided in bulk non-sterile form to manufacturers of procedure kits for inclusion as an accessory component.
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