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510(k) Data Aggregation

    K Number
    K171483
    Device Name
    ArchFlo CT Midline
    Manufacturer
    Medcomp (dba Medical Components, Inc.)
    Date Cleared
    2017-12-15

    (207 days)

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

    Medcomp (dba Medical Components, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.
    Device Description
    The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
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    K Number
    K171618
    Device Name
    Symetrex Long Term Hemodialysis Catheter
    Manufacturer
    Medcomp (DBA Medical Components, Inc.)
    Date Cleared
    2017-11-16

    (167 days)

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

    Medcomp (DBA Medical Components, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.
    Device Description
    The Symetrex™ Long Term Hemodialysis Catheter 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 arochr 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
    K171333
    Device Name
    20G x 5/8 Pro-Lock CT Safety Infusion Set
    Manufacturer
    Medcomp (dba Medical Components, Inc.)
    Date Cleared
    2017-07-18

    (71 days)

    Product Code
    PTI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medcomp (dba Medical Components, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.
    Device Description
    The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged. The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.
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