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510(k) Data Aggregation

    K Number
    K021704
    Device Name
    VAXCEL PICC WITH PASV VALVE TECHNOLOGY
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    2002-06-06

    (14 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vaxcel ™ PICC with PASV®Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, and piotics, chemotherapy, analgesics, nutitional therapy, and blood products, and blood indicated for blood specimen withdrawal.
    Device Description
    The Vaxcel™ PICC with PASV® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal.
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    K Number
    K010349
    Device Name
    DUAL LUMEN MIDLINE CATHETER
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    2001-02-28

    (23 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003642
    Device Name
    PLACEMENT-PLUS
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    2000-12-20

    (23 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993860
    Device Name
    CATHETER INNOVATIONS IMPLANTABLE PORT
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    1999-12-03

    (18 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. They are also indicated for blood specimen withdrawal.
    Device Description
    Catheter Innovations. Inc. Implantable Ports are constructed using a combination of traditional implanted port/catheter technology and materials which are well known and proven in the art (over fifteen years of successful use), Bard Access Systems BardPort™ Implanted Ports with Groshong® catheters-hereafter referred to as BardPorts™ (over eleven years in use) and our own previously approved 510(k) technology. The Catheter Innovations ports, like the BardPorts™ and other traditional ports are implanted within the body. They are used for access to the circulatory system for repeatable or periodic infusion of fluids and/or aspiration of blood. Like many currently marketed ports the Catheter Innovations ports have smooth, contoured titanium (or proposed polysulfone plastic) port bodies with either one (single-lumen) or two (dual-lumen) independent reservoirs. A radiopaque silicone catheter with one or two lumens is provided with each port body. The catheter may come attached to the port body by the manufacturer or unattached depending on user preference. If the catheter comes attached to the port, at the time of use the health practitioner measures and cuts off the distal end of the catheter to the desired length. If the catheter is not attached to the port when it is purchased, the catheter is placed, then cut off at the proximal end to the desired length and attached to the port by the practitioner. The port is then placed in a small pocket made just under the skin. The port bodies are designed to facilitate secure seating and anchoring in the port pocket. The ports are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps the port body reservoirs. Both BardPorts™ and Catheter Innovations ports contain a thin silicone membrane within their construction. In both cases these membranes have a small slit or cut through them that acts as a valve. In the BardPorts™ this valve is located at the distal end of the attached catheter. In the Catheter Innovations ports the valve is located in a small plastic polysulfone housing which comes attached to the port body. The catheter is connected to this port through this housing. In both examples the valve is used to control the flow of fluids both into and out of the blood stream. The valve remains closed when the ports are not in use and when subjected to normal central venous pressures. When positive fluid pressure is applied through the reservoir, the valve opens, allowing infusion through the catheter. When negative pressure (aspiration) is applied, the valve opens, allowing for withdrawal of blood into a syringe.
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    K Number
    K991897
    Device Name
    CATHETER INNOVATIONS IMPLANTABLE PORT
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    1999-10-21

    (139 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.
    Device Description
    Catheter Innovations, Inc. Implantable Ports are constructed using a combination of traditional implanted port/catheter technology which is well known in the art (over fifteen years of successful use), Bard Access Systems BardPort™ Implanted Ports with Groshong® catheters-hereafter referred to as BardPorts™ (over eleven years in use) and its own previously approved 510(k) technology. The Catheter Innovations ports, like the BardPorts™ and other traditional ports, are implanted within the body and are used for access to the circulatory system for repeatable or periodic infusion of fluids and/or aspiration of blood. Like many currently marketed ports the Catheter Innovations ports have smooth, contoured titanium port bodies with either one (single-lumen) or two (dual-lumen) independent reservoirs. A radiopaque silicone catheter with one or two lumens is provided with each port body. The catheter may come attached to the port body by the manufacturer or un-attached depending on user preference. If the catheter comes attached to the port, at the time of use the health practitioner measures and cuts off the distal end of the catheter to the desired length. If the catheter is not attached to the port when it is purchased, the catheter is placed, then cut off at the proximal end to the desired length and attached to the port by the practitioner. The port is then placed in a small pocket made just under the skin. The port bodies are designed to facilitate secure seating and anchoring in the port pocket. The port bodies are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps these reservoirs. Both BardPorts™ and Catheter Innovations ports contain a thin silicone membrane within their construction. In both cases these membranes have a small slit or cut through them that acts as a valve. In the BardPorts™ this valve is located at the distal end of the attached catheter. In the Catheter Innovations ports the valve is located in a small plastic polysulfone housing which comes attached to the port body. The catheter is connected to this port through this housing. In both examples the valve is used to control the flow of fluids both into and out of the blood stream. The valve remains closed when the ports are not in use and when subjected to normal central venous pressures. When positive fluid pressure is applied through the reservoir, the valve opens, allowing infusion through the catheter. When negative pressure (aspiration) is applied, the valve opens, allowing for withdrawal of blood into a syringe.
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    K Number
    K981368
    Device Name
    PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    1998-05-01

    (16 days)

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

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children and infants who require intravenous therapy. Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheters (PICC) have the same intended use as our Single Lumen PICC Catheters (K963097).
    Device Description
    PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC)
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    K Number
    K981382
    Device Name
    PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    1998-05-01

    (15 days)

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

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children and infants who require intravenous therapy. Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following: - Hypertonic nutrition solutions with final glucose concentrations . greater than 10% - Continuously infused Vesicant Drugs . - Any medication contraindicated for infusion into the peripheral . system Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).
    Device Description
    PASV™ Dual Lumen Peripherally Inserted Midline Catheter
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    K Number
    K980127
    Device Name
    6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
    Manufacturer
    CATHETER INNOVATIONS, INC.
    Date Cleared
    1998-03-11

    (56 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATHETER INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.
    Device Description
    Catheter Innovations, Inc. Extension Sets with PASV™ Valve
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