Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K024007
    Device Name
    SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J
    Manufacturer
    SUNDER BIOMEDICAL TECH. CO., LTD.
    Date Cleared
    2003-07-14

    (222 days)

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

    SUNDER BIOMEDICAL TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and continuous or intermittent drug infusion. - Patients requiring multiple sites for IV access. - Patients lacking useable peripheral IV sites. - Patients requiring central venous pressure monitoring. - Patients requiring total parenteral nutrition. - Patients receiving incompatible medications. - Patients requiring multiple infusions of fluids, medications, or chemotherapy. - . Patients subject to frequent blood sampling or receiving blood transfusions. - Patients receiving infusions that are hypertonic, hyperosmolar or infusions that have divergent pH values.
    Device Description
    The medical device made by Sunder Biomedical Tech, CO., LTD are triple-lumen. polyurethane catheter, 5.5 and 7.0 French in size, with three independent non-communication lumens, extension lines, luer hubs and slide clamps, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior). Central Venous Catheter (CVC) - a tubular device with single lumen or rnulti-lumen catheter, or cannula, placed within a vein and whose distal end is intended to be located within the vena cava (inferior of superior). The catheterization kit components are configured in a Polyester Terephthalate (PET) tray and sealed with a Tyvek lid stock, and sterilized.
    Ask a Question
    K Number
    K014140
    Device Name
    RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
    Manufacturer
    SUNDER BIOMEDICAL TECH. CO., LTD.
    Date Cleared
    2002-11-18

    (336 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNDER BIOMEDICAL TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RENAX (SUNDER) HEMODIALYSIS BLOOD TUBING SET (model: SD-K01, SD-G01) is intended to serve as a conduit through which blood is taken from the patient, delivered to the hemodialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.
    Device Description
    Not Found
    Ask a Question
    K Number
    K003123
    Device Name
    RENAX A.V. FISTULA NEEDLE SETS
    Manufacturer
    SUNDER BIOMEDICAL TECH. CO., LTD.
    Date Cleared
    2001-05-04

    (211 days)

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

    SUNDER BIOMEDICAL TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1