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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?
    Product Code :

    MSD

    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
    K210461
    Device Name
    End Cap
    Manufacturer
    Medical Components Inc. (Medcomp)
    Date Cleared
    2021-09-14

    (210 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Luer lock plug for capping male or female luer tapers for hemodialysis catheters.
    Device Description
    The Medcomp® End cap is non-vented plastic cap with a male luer. The end connects directly to the female luer of the catheter.
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    K Number
    K203575
    Device Name
    GlidePath Retro Long-Term Hemodialysis Catheter
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2021-07-01

    (206 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlidePath™ Retro Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion.
    Device Description
    The GlidePath™ Retro Long-Term Hemodialysis Catheter features a dual-lumen polyurethane catheter shaft with optimized double-D cross-sectional design providing separate arterial and venous lumens, an external bifurcation hub with SwiftClick connector assembled by physician upon placement, and arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths.
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    K Number
    K211410
    Device Name
    GlidePath 13F Long-Term Hemodialysis Catheter
    Manufacturer
    Bard Peripheral Vascular, Inc
    Date Cleared
    2021-06-04

    (29 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlidePath™ 13F long-term hemodialysis catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 34 cm are intended for femoral vein insertion.
    Device Description
    The GlidePath™ 13F Long-Term Hemodialysis Catheter is a vascular access device, intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy and features a dual-lumen, optimized double-D cross-sectional catheter shaft with a fixed symmetrical tip design. The catheter has separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial (red) luer and venous (blue) luer and extension legs which connect to an external dialysis machine or blood cleansing device. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow and aid in overthe-guidewire placement. The GlidePath™ 13F Long-Term Hemodialysis Catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The device is intended for single patient use only.
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    K Number
    K203767
    Device Name
    Pristine Long-Term Hemodialysis Catheter
    Manufacturer
    C B Bard, Inc
    Date Cleared
    2021-04-02

    (100 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
    Device Description
    The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.
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    K Number
    K202150
    Device Name
    GlidePath 7.5F Long-Term Dialysis Catheter
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2020-11-18

    (107 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlidePath™ 7.5F Long-Term Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access in pediatric, adolescent, and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, subclavian vein, or femoral vein.
    Device Description
    The GlidePath™ 7.5F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include smaller lumen diameter and shorter lengths, 8 cm to 19 cm, tip to cuff measurement. Additionally, GlidePath™ 7.5F Long-Term Hemodialysis Catheters have been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.
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    K Number
    K202176
    Device Name
    Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
    Manufacturer
    Medical Components Inc. (Dba Medcomp)
    Date Cleared
    2020-09-03

    (30 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a symmetric tip dual lumen catheter designed for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement. Long term, greater than 30 days, vascular access for Hemodialysis and Apheresis treatments.
    Device Description
    The Symetrex® Long Term Hemodialysis Catheter & Symetrex® Long Term Hemodialysis Catheter with Sideholes is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to anchor the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.
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    K Number
    K200627
    Device Name
    GlidePath 10F Long-Term Dialysis Catheter
    Manufacturer
    C R Bard, Inc
    Date Cleared
    2020-06-22

    (104 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.
    Device Description
    The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.
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    K Number
    K190527
    Device Name
    GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
    Manufacturer
    C.R. Bard
    Date Cleared
    2020-03-05

    (367 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GlidePath™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40cm are intended for femoral vein insertion. The HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.
    Device Description
    The GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters feature a dual-lumen shaft with double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. Both the staggered and symmetrical catheter tips contain holes that aid in the distribution of blood flow or aid in over-the-quidewire placement. The dialysis catheters are offered in various lengths in straight or Alphacurve™ configurations. Alphacurve™ configurations feature a pre-formed, ~225 ° curve. Long-term dialysis catheters are tunneled to provide greater distance between the skin and entry site into the vein and provide a physical barrier to the migration of skin organisms. The HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters feature a fixed, staggered distal tip. This tip design is identical to that of the predicate devices, HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters, cleared August 12, 2005 under K051748. The GlidePath™ Long-Term Dialysis Catheters, launched in February 2013, are a modification of the HemoStar™ Long-Term Dialysis Catheters. GlidePath™ catheters feature an optimized catheter shaft extrusion profile and a modified tip which is fixed and symmetrical, allowing for reduced luminal pressure during use. The GlidePath™ catheters also include a preloaded stylet for ease of placement. This accessory was previously cleared under K090101. The changes to the catheter were documented via internal note to file prior to launch in 2013.
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    K Number
    K182443
    Device Name
    Pristine Hemodialysis Catheter
    Manufacturer
    Pristine Access Technologies Ltd.
    Date Cleared
    2019-05-31

    (266 days)

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

    MSD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
    Device Description
    Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter junction and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
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