Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    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?
    Product Code :

    FOS

    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.
    Ask a Question
    K Number
    K130725
    Device Name
    MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Date Cleared
    2013-04-17

    (30 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Argyle™ Polyurethane Umbilical Vessel Catheter is intended for short-term vascular access via umbilical vessels in neonatal patients.
    Device Description
    The Argyle™ Polyurethane Umbilical Vessel Catheter is a single-lumen catheter made of a polyurethane catheter tube which is insert molded to a polypropylene hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion. Encapsulated within the catheter walls are three barium sulfate strips spaced 120° apart, which run the length of the catheter. 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 25 cm from the tip. Catheter placement must be confirmed by x-ray. The Argyle Polyurethane Umbilical Vessel Catheter will continue to be available in three sizes: 2.5 Fr.; 3.5 Fr.; and 5 Fr. Each device will continue to be packaged in a Tyvek pouch; 10 pouches are packaged in a carton. The Argyle Polyurethane Umbilical Vessel Catheter does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging is not made of natural rubber latex.
    Ask a Question
    K Number
    K120304
    Device Name
    FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Date Cleared
    2012-03-01

    (29 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.
    Device Description
    FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
    Ask a Question
    K Number
    K091213
    Device Name
    FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-25

    (151 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.
    Device Description
    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.
    Ask a Question
    K Number
    K091214
    Device Name
    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-25

    (151 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS CATHETER IS FOR USE IN NEWBORN PEDIATRIC OR NEONATAL PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE AND ADMINISTER I.V.FLUIDS THROUGH AN UMBILICAL VESSEL.
    Device Description
    Not Found
    Ask a Question
    K Number
    K081515
    Device Name
    NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2008-07-21

    (52 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoMed Dual Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood, monitor blood pressure, or administer fluids intravenously.
    Device Description
    The NeoMed Dual Lumen Umbilical Catheter is a silicone dual lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a dual lumen umbilical catheter, a hub, and two extension legs, one with a three-way stopcock and the other with an injection site.
    Ask a Question
    K Number
    K073596
    Device Name
    NEOMED SINGLE LUMEN UMBILICAL CATHETER
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2008-02-22

    (63 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo Med Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to sample blood , monitor blood parties of administer Fluids intravenously
    Device Description
    The NeoMed Single Lumen Umbilical Catheter is a silicone single lumen catheter with natural white barium sulfate included for radiopacity. The device consists of the following main components: a single lumen umbilical catheter, a hub, and a luer lock connector, and 3 way stopcock with 2 female type connectors.
    Ask a Question
    K Number
    K981630
    Device Name
    VYGON DOUBLE LUMEN UMBILICAL CATHETER
    Manufacturer
    SCHIFF & CO.
    Date Cleared
    1998-10-01

    (147 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatable solutions, through separate lumens.
    Device Description
    Double Lumen Umbilical Catheter
    Ask a Question
    K Number
    K963972
    Device Name
    NEO-CARE DUAL LUMEN UMBILICAL CATHETER
    Manufacturer
    KLEIN-BAKER MEDICAL, INC.
    Date Cleared
    1996-12-24

    (82 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Why did this record match?
    Product Code :

    FOS

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

    Page 1 of 1