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510(k) Data Aggregation

    K Number
    K130855
    Device Name
    PTFE SUPER SHEATH INTRODUCER
    Manufacturer
    MARTECH MEDICAL PRODUCTS
    Date Cleared
    2013-07-29

    (123 days)

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

    MARTECH MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
    Device Description
    The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vasular access for placement of intravascular catheters. Inserting an introducer needle into the desired vessel allows for initial access to the vascular system. A guide wire is then placed into the vessel through the needle and the needle is then removed. The sheath/dilator assembly is then inserted over the guide wire and into the percutaneous opening to dilate the opening into the vessel. The dilator and guide wire are then removed leaving the sheath in place. A catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. Its frame is composed of Teflon, HDPE, and Nylon. The sheath hub and dilator hub all HPDE, while the sheath tube is PTFE (Teflon) and the dilator is either Nylon for the 3F through the 5.5F sizes or HDPE for the 6F through 9F sizes. The Super Sheath's sheath is gray in color, with either a Light Blue Nylon dilator (3F-5.5F) or gray HDPE dilator (6F-9F). The dilator hub is composed of a different color to identify each individual French size (3F Purple, 3.5F Pink, 4F Red, 4.5F Yellow. 5F Light Gray, 5.5F Dark Gray, 6F Green, 6.5F Light Green, 7F Orange, 8F Blue, and 9F White), The PTFE Super Sheath 2.0 is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available with 5cm, 7cm or 10cm length options.
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    K Number
    K120617
    Device Name
    PTFE SUPER SHEATH INTRODUCER
    Manufacturer
    MARTECH MEDICAL PRODUCTS
    Date Cleared
    2012-11-19

    (264 days)

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

    MARTECH MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.
    Device Description
    The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vascular access for placement of intravascular catheters. Inserting an introducer needle into the desired vessel allows for initial access to the vascular system. A guide wire is then placed into the vessel through the needle and the needle is then removed. The sheath/dilator assembly is then inserted over the guide wire and into the percutaneous opening to dilate the opening into the vessel. The dilator and guide wire are then removed leaving the sheath in place. A catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. Its frame is composed of mostly HDPE, as the sheath hub, dilator and dilator hub are all HPDE. The sheath tube is composed of PTFE (Teflon). The Super Sheath if gray in color with the exception of the dilator hub which is composed of a different color to identify each individual French size (3F Purple, 3.5F Pink, 4F Red, 4.5F Yellow, 5F Light Gray, 5.5F Dark Gray, 6F Green, 6.5F Light Green, 7F Orange, 8F Blue, and 9F White). The PTFE Super Sheath is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available 3F-7F with a Scm length or 3F-9F in the 10cm length option.
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    K Number
    K101399
    Device Name
    COAXIAL INTRODUCER SET
    Manufacturer
    MARTECH MEDICAL PRODUCTS
    Date Cleared
    2010-06-17

    (30 days)

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

    MARTECH MEDICAL PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coaxial Introducer Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The Coaxial Introducer Set is designed to provide dilation of the initial entry point and provide a channel for attaining vascular access. The coaxial introducer consists of an inner dilator within a slightly shorter outer sheath. The kit contains a 21 gauge introducer needle, a .018" diameter guidewire, and a 4F or 5F coaxial introducer. The coaxial introducer is offered in a standard and stiff version. The Coaxial Introducer Set is provided in sterile and non-sterile configurations.
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    K Number
    K960519
    Device Name
    MARTECH ENDOSCOPIC INJECTION NEEDLE
    Manufacturer
    MARTECH MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-05-01

    (86 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARTECH MEDICAL PRODUCTS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.
    Device Description
    The Martech Endoscopic Injection Needle fits within various endoscopes with working channels having a 5 French or larger inner diameter and extends beyond the proximal end of the endoscope. The Endoscopic Injection Needle is sterile, disposable and nonpyrogenic. It consists of a non-coring, 23 gauge stainless steel needle attached to a flexibe, 5 French polycarbonate catheter with luer lock hub. The luer lock hubs are designed to meet the "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983). Moreover, these luer lock hubs are designed to accommodate standard syringes. To allow for smooth passage of the device through the endoscope's instrument channel, the transition between the needle and catheter assembly is tapered. The Endoscopic Injection Needle will be provided in a variety of lengths, up to 200 cm, in order to accommodate for different length instrument channels. The needle length will be specified on the device's unit label. In general, the shorter needles with shorter endoscopes such as bronchoscopes and the longer needles may be used with longer endoscopes such as flexible gastroscopes and colonoscopes.
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