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510(k) Data Aggregation

    K Number
    K232945
    Device Name
    Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
    Manufacturer
    Medical Components Inc. (Dba MedComp)
    Date Cleared
    2023-11-16

    (57 days)

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

    Medical Components Inc. (Dba MedComp)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trio-CT® Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. • The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
    Device Description
    The Trio-CT® Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The catheter is available with straight or curved extensions in a variety of lengths to accommodate physician preference and clinical needs. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
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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?
    Applicant Name (Manufacturer) :

    Medical Components Inc. (Dba Medcomp)

    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
    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?
    Applicant Name (Manufacturer) :

    Medical Components Inc. (dba MedComp)

    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
    K183219
    Device Name
    Trio-CT Triple Lumen Catheter
    Manufacturer
    Medical Components Inc. (dba MedComp)
    Date Cleared
    2019-06-14

    (206 days)

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

    Medical Components Inc. (dba MedComp)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Trio-CT™ Triple Lumen Catheter is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis and apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring. The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.
    Device Description
    The Trio-CT™ Triple Lumen Catheter is a short-term (less than 30 days) dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (purple) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, power injection of contrast media, central venous pressure monitoring, blood draws and infusion of medications. The attachable suture wing can be used to provide additional catheter securement and to minimize movement at the exit site.
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    K Number
    K181175
    Device Name
    12F Tri-Flow Triple Lumen Catheter
    Manufacturer
    Medical Components Inc. (Dba Medcomp)
    Date Cleared
    2018-07-05

    (64 days)

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

    Medical Components Inc. (Dba Medcomp)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis 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. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.
    Device Description
    The 12F Tri-Flow Triple Lumen Catheter is a short term dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.
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