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510(k) Data Aggregation

    K Number
    K222170
    Device Name
    Power Acute Triple Lumen Hemodialysis Catheter
    Manufacturer
    Health Line International Corporation
    Date Cleared
    2023-01-13

    (176 days)

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

    Health Line International Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
    Device Description
    The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.
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    K Number
    K200426
    Device Name
    Acute Dual Lumen Hemodialysis Catheter
    Manufacturer
    Health Line International Corporation
    Date Cleared
    2020-12-24

    (307 days)

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

    Health Line International Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.
    Device Description
    The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.
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    K Number
    K200263
    Device Name
    Health Line CT Midline Catheter
    Manufacturer
    Health Line International Corporation
    Date Cleared
    2020-03-12

    (38 days)

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

    Health Line International Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEALTH LINE CT MIDLINE CATHETER is indicated for short term (less than 30 days) access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The HEALTH LINE CT MIDLINE CATHETER is suitable for use with power injectors.
    Device Description
    The HEALTH LINE CT MIDLINE CATHETER is a family of peripherally inserted peripheral catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous micro introducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access. The HEALTH LINE CT MIDLINE CATHETER is indicated for dwell times shorter than 30 days. The HEALTH LINE CT MIDLINE CATHETER product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The HEALTH LINE CT MIDLINE CATHETER's are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
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    K Number
    K192533
    Device Name
    Health Line CT CVC
    Manufacturer
    Health Line International Corporation
    Date Cleared
    2019-12-10

    (85 days)

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

    Health Line International Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.
    Device Description
    The HEALTH LINE CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each HEALTH LINE CT CVC has a kink resistant, gradual tapered catheter design. The HEALTH LINE CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and nonpyrogenic in a variety of kit configurations. The HEALTH LINE CT CVC is indicated for dwell times shorter than 30 days. The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. The HEALTH LINE CT CVC product line has catheters in 16 G and 14 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All HEALTH LINE CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
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    K Number
    K160448
    Device Name
    ARTLINE
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION
    Date Cleared
    2016-07-12

    (145 days)

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

    HEALTH LINE INTERNATIONAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).
    Device Description
    The ARTLINE is a single lumen peripherally inserted catheter device designed to perform short term access to the peripheral arterial circulatory system for less than 30 days. The catheter, made of radiopaque polyurethane tubing, echogenic needle, guidewire with slide advancer. Each ARTLINE has a kink resistant catheter design. The catheter is inserted over the needle into the peripheral arterial vessel, the guide wire is advanced and the catheter is threaded over the guide wire. The catheter is supplied sterile and non-pyrogenic. The ARTLINE is indicated for dwell times shorter than 30 days. The ARTLINE is a 20ga single lumen catheter. The catheter is approximately 4.45 cm long. The catheters are attached to an injectionmolded polyurethane hub with Luer lock fittings for access attachment.
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    K Number
    K140270
    Device Name
    NEXUS MIDLINE CT CATHETER
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION
    Date Cleared
    2014-08-20

    (198 days)

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

    HEALTH LINE INTERNATIONAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors.
    Device Description
    The NEXUS™ MIDLINE CT Catheter is a family of peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access. The NEXUS™ MIDLINE CT Catheter is indicated for dwell times shorter than 30 days. The NEXUS™ MIDLINE CT Catheter product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The NEXUS™ MIDLINE CT Catheters are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
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    K Number
    K130851
    Device Name
    CASCADE HEMODIALYSIS/APHERESIS CATHETER
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION
    Date Cleared
    2014-01-09

    (288 days)

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

    HEALTH LINE INTERNATIONAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CASCADE™ Hemodialysis/Apheresis Catheter is intended for use in attaining long-term vascular access for Hemodialysis therapy and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein, as required. Indications For Use: - The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining . Long-Term (greater than 30 days) vascular access for Hemodialysis therapy and Apheresis. - It may be inserted percutaneously and is primarily placed in the internal jugular vein ● of an adult patient. - Alternate insertion sites include subclavian vein as required. . - Catheters greater than 40 cm are intended for femoral vein insertion. . - . The curved CASCADE™ Hemodialysis/Apheresis Catheter is intended for internal jugular vein insertion.
    Device Description
    The CASCADE™ Hemodialysis/Apheresis Catheter is a family of percutaneously inserted catheters designed to perform Hemodialysis therapy and Apheresis. The catheters are manufactured from medical grade radiopaque silicone material, which provides increased patient comfort while offering excellent biocompatibility. The CASCADE™ Hemodialysis/Apheresis Catheter Kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for dwell times greater than 30 days. The CASCADE™ Hemodialysis/Apheresis Catheter product line has catheters in 12.5 Fr dual lumen sizes. Catheters range from approximately 13 - 55 cm long and are offered in straight or curved catheter configurations with cuffs for long-term implantation. The catheters are attached to an injection-molded silicone hub that has a suture wing and extension legs with Luer lock fittings for access attachment.
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    K Number
    K130034
    Device Name
    UNI-PICC
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION
    Date Cleared
    2013-03-08

    (60 days)

    Product Code
    LJS, REG
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH LINE INTERNATIONAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNI-PICC™ is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy and for blood sampling. The UNI-PICC™ Peripherally Inserted Central Catheter is indicated for short or long term access to the central venous system for intravenous administration of fluids, medications and/or nutritional therapy when prescribed. Blood sampling may also be conducted with UNI-PICC™. The 3F UNI-PICC™ Peripherally inserted Central Catheter is indicated for short or long term access to the central venous system via peripheral insertion in neonates, infants and children. It may be used for administration of fluids, medications and/or nutritional therapy when prescribed.
    Device Description
    The UNI-PICC™ is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each UNI-PICC™ has a kink resistant catheter design. The UNI-PICC™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The UNI-PICC™ is indicated for dwell times shorter or greater than 30 days. The UNI-PICC™ product line has catheters in 3Fr, 4 Fr and 5 Fr single lumen, 4 Fr, 5 Fr and 6 Fr dual lumen and 5 Fr and 6 Fr triple lumen. All catheters range from approximately 30 - 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
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    K Number
    K113622
    Device Name
    ORION II CT CVC
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
    Date Cleared
    2012-05-18

    (162 days)

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

    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORION™ II CT CVC is intended to be used by medical professionals for short-term access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. All ORION™ II CT CVC products have a maximum · recommended infusion rating of 5 ml/sec. The ORION™ II CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the ORION™ III CT CVC.
    Device Description
    The ORION™ II CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies, The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each ORION™ II CT CVC has a kink resistant, gradual tapered catheter design. The ORION™ II CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The ORION™ II CT CVC is indicated for dwell times shorter than 30 days. The ORION™ II CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. The ORION™ II CT CVC product line has catheters in 16 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All ORION™ II CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
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    K Number
    K120548
    Device Name
    HLIC NEEDLE-LESS VALVE
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION
    Date Cleared
    2012-05-04

    (71 days)

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

    HEALTH LINE INTERNATIONAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HLIC Needle-Less Valve is intended to allow access to IV administration sets, medication vials, blood donor collection bags, and solution bags with one convenient device without the use of needles or blunt cannulas.
    Device Description
    The HLIC Needle-Less Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position, it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.
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