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    K Number
    K203487
    Device Name
    Drakon and Sequre Microcatheters
    Manufacturer
    Accurate Medical Therapeutics Ltd
    Date Cleared
    2020-12-11

    (14 days)

    Product Code
    DQO, DRA
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accurate Medical Therapeutics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drakon™ and Sequre® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and Sequre® microcatheters are also intended for drug infusion in intraarterial therapy and infusion of embolic materials. The Drakon™ and Sequre® microcatheters should not be used in cerebral vessels.
    Device Description
    The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 1.9 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
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    K Number
    K202797
    Device Name
    Drakon and Sequre Microcatheters
    Manufacturer
    Accurate Medical Therapeutics Ltd.
    Date Cleared
    2020-10-23

    (30 days)

    Product Code
    DQO, DRA
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accurate Medical Therapeutics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
    Device Description
    The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer laver. which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
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    K Number
    K173430
    Device Name
    SeQure® NF and SeQure® Microcatheters
    Manufacturer
    Accurate Medical Therapeutics Ltd.
    Date Cleared
    2018-01-26

    (85 days)

    Product Code
    DQO, DOO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Accurate Medical Therapeutics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The SeQure® NF and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.
    Device Description
    The SeQure® NF and SeQure® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The SeQure®'s distal end has side holes and two radiopaque markers while the SeQure® NF's distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The SeQure® NF and the SeQure® microcatheters are sterile single lumen devices and are available in several different diameters and lengths.
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