Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K200373
    Device Name
    Deltaven Fast Flash Closed I.V. Catheter Systems
    Manufacturer
    Date Cleared
    2020-08-26

    (194 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Delta Med Spa

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly. Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries. Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. Deltaven Fast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector. Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.
    Device Description
    The devices consist of an over-the-needle, peripheral intravascular catheter made of polyurethane, integrated extension tubing with Luer lock adaptor and slide clamp. The devices are also equipped with a Luer lock final adaptor (single entry version) or a Y Luer lock final adapter (dual entry version).
    Ask a Question

    Ask a specific question about this device

    K Number
    K171530
    Device Name
    Deltaven XiV Max, Deltaven XiV Max FF
    Manufacturer
    Date Cleared
    2017-12-21

    (210 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Delta Med SpA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Deltaven Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly. Deltaven Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries. Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. Deltaven Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector. Deltaven Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.
    Device Description
    The devices consist of an over-the-needle, peripheral intravascular catheter made of polyurethane, integrated extension tubing with Luer lock adaptor and slide clamp. The devices are also equipped with a Luer lock final adaptor (single entry version) or a Y Luer lock final adapter (dual entry version). Deltaven Closed I.V. Catheters are available in five versions, as follows: - Deltaven XiV Max - . Deltaven XiV Max Y - Deltaven XiV Max SC ● - Deltaven XiV Max Y-NL ● - Deltaven XiV Max SC-NL The same versions are available with the needle provided with a notch along its surface that permits the early visualization of blood return inside the catheter tube. This version is generally named as Deltaven XV Max Fast Flash and is available in five versions, as follows: - . Deltaven XiV Max Fast Flash - Deltaven XiV Max Y Fast Flash - Deltaven XiV Max SC Fast Flash - Deltaven XiV Max Y- NL Fast Flash - . Deltaven XiV Max SC-NL Fast Flash The devices provided with single entry Luer lock adaptors are also equipped with: - Luer lock white cap - 3 way stopcock - 3 way stopcock and needleless valve ● The devices provided with dual entry Luer lock adaptors are also equipped with: - Luer lock white cap ● - Needleless valve connector
    Ask a Question

    Ask a specific question about this device

    K Number
    K140175
    Device Name
    INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    Date Cleared
    2014-08-05

    (194 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    DELTA MED SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Delta Fly F20μ Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.
    Device Description
    The Delta Med Delta Fly Winged Safety Needles are available in four versions, as follows: - o Delta Fly F20μ Micro Bore Winged Safety Needle 25G x 35 cm - . Delta Fly F20μ Micro Bore Winged Safety Needle 23G x 35 cm - Delta Fly Micro Bore Winged Safety Needle 25G x 35 cm ● - Delta Fly Micro Bore Winged Safety Needle 23G x 35 cm The devices consist of a stainless steel needle encased in a body of plastic material, attached to a micro bore tube, ending proximally with a female Luer lock fitting closed by a final male Luer lock cap. The female Luer lock fitting includes a 20μ woven mesh filter in the F20μ versions of the device. The devices are equipped with a passive needle stick safety system for covering the tip of the needle upon needle withdrawal, in order to protect the operator from accidental needle stick injury. To help identification between the two types (with and without filter), the male Luer lock proximal end cap is colored white on the versions with the filter and is transparent on the versions without the filter. To identify the needle size of each version, the winged body of the devices are color-coded blue for the 23G versions and orange for the 25G versions. The distal end of the device is a stainless steel needle point has a triple bevel design. At the proximal end is a Luer lock fitting. Both device versions (with and without the mesh filter) have a final female connection in compliance with the requirements of ISO 594-2. Delta Fly Micro Bore Winged Safety Needles are supplied for short term use only, sterile for single use, sterilized with ethylene oxide (EO) gas, and meet the biocompatibility requirements of ISO 10993-1:2009.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1