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510(k) Data Aggregation

    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?
    Product Code :

    MPB

    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
    K192807
    Device Name
    Duo-Flow Side x Side Double Lumen Catheter
    Manufacturer
    Medical Components Inc. (dba MedComp)
    Date Cleared
    2020-04-23

    (205 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
    Device Description
    The Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter with two lumens. The red adapter connects to the proximal lumen for "arterial" outflow, and the blue adapter connects to the distal lumen for "venous" return. The catheter is available in various sizes and configurations (curved or straight extensions).
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    K Number
    K192302
    Device Name
    Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
    Manufacturer
    Covidien, llc
    Date Cleared
    2020-01-17

    (147 days)

    Product Code
    MPB, NIE
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins. The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion. The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion. The Mahurkar(TM) Acute High Pressure Triple Lumen Catheters are intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
    Device Description
    The Mahurkar™ Acute Single Lumen Catheter is a radiopaque, polyurethane tube that features a single-lumen design on the proximal end. A rotatable suture wing, for securing the catheter to the patient, is attached to the hub and five outflow holes are arranged in a spiral near the tapered tip. The single lumen catheter is available in 8.0 Fr outer diameter and in implant lengths 15 cm and 19.5 cm. An optional, disposable Y-adapter can be used to convert the single extension to a dual. The Mahurkan™ Acute Dual Lumen Catheter is a radiopaque, polyurethane tube that features a two-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a dual lumen shaft that is available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 8.0 Fr. 10.0 Fr. 11.5 Fr. or 13.5 Fr outer diameters and a variety of implant lengths ranging from 9 cm to 24 cm. It is offered as a single device or as convenience kits. The Mahurkar™ Acute Triple Lumen Catheter and the Mahurkar™M Acute High Pressure Triple Lumen Catheter are radiopaque, polyurethane tubes that features a three-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 24 cm. They are offered as a single device or as convenience kits.
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    K Number
    K163458
    Device Name
    Zenysis Short-Term Dialysis Catheter
    Manufacturer
    C.R BARD. INC.
    Date Cleared
    2017-04-04

    (116 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.
    Device Description
    Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, and 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.
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    K Number
    K161504
    Device Name
    Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2017-01-06

    (219 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is intended for acute hemodialysis, apheresis and hemofiltration via percutaneous insertion into the subclavian, jugular, or femoral veins. The device is a short-term use catheter (less than 30 days).
    Device Description
    The Cook Turbo-Flo® HD Acute Hemodialysis Catheter Set/Tray is a short-term, 12 Fr, radiopaque polyurethane central venous catheter with two independent, noncommunicating lumens. Lengths of 15, 20, and 25 cm are available based on the anatomical needs of the patient.
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    K Number
    K153190
    Device Name
    Zenysis Short-Term Dialysis Catheter
    Manufacturer
    C.R BARD INC.
    Date Cleared
    2016-01-05

    (63 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required.
    Device Description
    Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs with Insertion Lengths of 15 cm, 20 cm, 24 cm and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.
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    K Number
    K122091
    Device Name
    COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
    Manufacturer
    COOK, INC.
    Date Cleared
    2013-07-29

    (378 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook Turbo-Flo® HD Acute Hemodialysis Catheter is intended for acute hemodialysis, apheresis and hemofiltration. It is intended for percutaneous insertion into the subclavian, jugular or femoral veins. The device is a short-term use catheter (less than 30 days).
    Device Description
    The Cook Turbo-Flo® HD Hemodialysis Catheters are short-term, 12 Fr., hydrophilically coated, radiopaque polyurethane central venous catheters with two independent, non-communicating lumens. Lengths of 15, 20 and 25 cm are available based on the anatomical needs of the patient. Various components may be included that are associated with placement of the device.
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    K Number
    K120674
    Device Name
    MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
    Manufacturer
    COVIDIEN
    Date Cleared
    2012-04-04

    (30 days)

    Product Code
    MPB, NIE
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mahurkar™ Elite Acute Dual Lumen Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion. The Mahurkar™ Elite Acute Triple Lumen 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 Mahurkar™ Elite Acute Dual Lumen Catheter features a two lumen design. The proximal end has color-coded adapters to indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a dual lumen shaft available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 12.0 Fr or 13.5 Fr outer diameters and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits. The Mahurkar™ Elite Acute Triple Lumen Catheter features a three lumen design. The proximal end has color-coded adapters to indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12.5 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.
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    K Number
    K110793
    Device Name
    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2011-12-16

    (269 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for acute hemodialysis and apheresis. They may be inserted perculaneously and are idealy placed in the internal jugularyon and apricless. They may be inserted percuraneously and an the internal jugular is the preferred site the preferred site.
    Device Description
    "Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits
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    K Number
    K102833
    Device Name
    DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
    Manufacturer
    FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
    Date Cleared
    2011-11-18

    (415 days)

    Product Code
    MPB
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    MPB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein.
    Device Description
    Disposable Hemodialysis Access Catheter Sets, including Single-lumen and Dual-lumen, are intended to attain long or short term (less than 30 days) vascular access for hemodialysis via the internal jugular, subclavian or femoral vein. It consists of a catheter, a puncture needle, a guide wire and a dilator. The set is provided EO sterilized.
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