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510(k) Data Aggregation

    K Number
    K142136
    Device Name
    ACCUCATH MIDLINE CATHETER SYSTEM
    Manufacturer
    VASCULAR PATHWAYS, INC.
    Date Cleared
    2015-01-08

    (157 days)

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

    VASCULAR PATHWAYS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (< 30 days) to sample blood, monitor blood pressure, and administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath® Midline is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 7mL/second.
    Device Description
    The AccuCath® Midline Catheter System has a usable length catheter of 3.1 inches in multiple Gauge sizes. The device(s) are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath® Midline is substantially equivalent functional characteristics and design to the predicates [Bard Access PowerGlide™ Device (K121073) and AccuCath® BC (K140504)]. The AccuCath® Midline catheter hub is identical in design to that of the AccuCath® BC's catheter's hub. including the built-in blood control septum. Additionally, the AccuCath® Midline, like the AccuCath® BC (K140504) predicate, consists of a radiopaque catheter with a blood control valve mechanism that is delivered over a guidewire with atraumatic coiled tip design; a notched needle to enhance flashback visualization, and a body / handle that serves as an integrated safety container to mitigate the risk of sharps injuries. The AccuCath® Midline is identical to the AccuCath BC® in that it features a septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure male luer connection is made. The flow path will remain opened once a secure male luer connection has been made.
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    K Number
    K140504
    Device Name
    ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
    Manufacturer
    VASCULAR PATHWAYS, INC.
    Date Cleared
    2014-07-17

    (140 days)

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

    VASCULAR PATHWAYS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.
    Device Description
    The AccuCath BC Intravascular Catheter System has a usable length catheter of 2.25 inches in 18, 20 and 22 Gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath BC catheter is identical to the AccuCath with the addition of needle echogenicity and a septum with plunger integrated into the catheter hub. The AccuCath BC catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. Similar to the original AccuCath system, the device is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a bier lock fitting, an echogenic needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.
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    K Number
    K112347
    Device Name
    RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
    Manufacturer
    VASCULAR PATHWAYS, INC.
    Date Cleared
    2011-09-22

    (38 days)

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

    VASCULAR PATHWAYS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
    Device Description
    The RIVS 18, 20 and 22 Gauge devices are single use, sterile intravascular catheters designed to provide access to veins. The devices are provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.
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    K Number
    K073241
    Device Name
    VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
    Manufacturer
    VASCULAR PATHWAYS
    Date Cleared
    2008-02-08

    (84 days)

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

    VASCULAR PATHWAYS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
    Device Description
    The device is a single use, sterile intravascular catheter designed to provide access to veins. The device is provided with a mechanism which allows the needle to be shielded following placement of the catheter.
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