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510(k) Data Aggregation

    K Number
    K241581
    Device Name
    Hemodialysis Catheter
    Manufacturer
    Haolang Medical USA Corporation
    Date Cleared
    2025-05-16

    (347 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Haolang Medical USA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis. * It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient. * Alternate insertion sites include subclavian vein as required. * Catheters greater than 40 cm are intended for femoral vein insertion. * The curved Hemodialysis Catheter is intended for internal jugular vein insertion. * 8-10Fr Hemodialysis Catheters can be used in pediatric patients.
    Device Description
    The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.
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    K Number
    K201726
    Device Name
    Arterial Catheter
    Manufacturer
    Haolang Medical USA Corporation
    Date Cleared
    2021-07-07

    (379 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Haolang Medical USA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arterial Catheter permits access to the peripheral arterial circulation.
    Device Description
    The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve. The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment. The Arterial Catheter is provided sterile.
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    K Number
    K201697
    Device Name
    Umbilical Vessels Catheter
    Manufacturer
    Haolang Medical USA Corporation
    Date Cleared
    2021-05-06

    (318 days)

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

    Haolang Medical USA Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients: Via the umbilical artery: --- sampling of blood, ---measurement of intravascular arterial pressure. Via the umbilical vein: --- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
    Device Description
    The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 40 cm from the tip. Catheter placement must be confirmed by x-ray. The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.
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