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510(k) Data Aggregation

    K Number
    K251253
    Device Name
    PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port
    Manufacturer
    Bard Access Systems, Inc.
    Date Cleared
    2025-06-18

    (56 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
    Device Description
    The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.
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    K Number
    K242328
    Device Name
    PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
    Manufacturer
    Bard Access Systems, Inc.
    Date Cleared
    2024-10-31

    (86 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I. V. Iluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
    Device Description
    The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.
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    K Number
    K232737
    Device Name
    PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port
    Manufacturer
    Bard Peripheral Vascular, Inc.
    Date Cleared
    2023-12-08

    (92 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
    Device Description
    The PowerPort™ implantable ports, including ECG Enabled Implantable Ports, are implantable access devices designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ implantable port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ implantable ports can be identified subcutaneously by feeling the top of the septum which includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Radiopaque identifiers for the PowerPort™ devices aid in identification as a BD power injectable port. The ECG Enabled Implantable Ports function identically to other PowerPort™ power-injectable ports with the option to use ECG instead of fluoroscopy during the implantation procedure for catheter advancement and tip location confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS). ECG technology provides real-time catheter tip location information and is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous access device (CVAD) tip placement confirmation. When used with the BD Sherlock 3CG+™ TCS, the Sherlock 3CG™ TPS stylet also provides the placer real-time feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG™ Tip Confirmation System (TCS) product and accessories are sold separately (refer to K180560, cleared 6/18/2018, for information on Sherlock 3CG+™ product and accessories).
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    K Number
    K190559
    Device Name
    SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
    Manufacturer
    AngioDynamics, Inc.
    Date Cleared
    2020-05-22

    (444 days)

    Product Code
    LJT, REG
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine. When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.
    Device Description
    The SmartPort* device with ENDEXO and Vortex Technology and the SmartPort Plastic device with Vortex Technology are implantable venous access devices designed for repeated access to the vascular system. The SmartPort* and SmartPort Plastic devices are subcutaneous implant devices with one reservoir. The ports are accessed using a Huber needle which is passed through the self-sealing silicone septum covering the reservoir. When used with power injectable needles, the port can be used for power injection of contrast media and contrast enhanced computed tomography (CECT). Available in plastic and titanium port bodies, the SmartPort* device has standard, low profile, and mini Titanium port configurations and low-profile Plastic port configurations. The ports are offered with a 5F, 6F or 8F single lumen BioFlo catheter. The BioFlo catheter with ENDEXO technology is present in the previously cleared NMI Port II (K131694) for improved resistance to thrombus accumulation and/or formation on the catheter. The outlet of the vortex port chamber is set at a tangent rather than perpendicularly. The SmartPort Plastic device is offered in a low-profile Plastic port body configuration with a 6F or 8F single lumen polyurethane catheter. Both the BioFlo and polyurethane catheters are radiopague. When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate setting is 5 ml/s with 19G or 20G non-coring power injectable needles or 2 ml/s with a 22G non-coring power injectable needle. The ports are available with either silicone filled suture fixation holes. If desired, the suture fixation holes can be used to anchor the port to the subcutaneous tissue. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter is marked at every centimeter and can be cut to the desired length. The ports are packaged with procedural accessories in a kit to the end user
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    K Number
    K181446
    Device Name
    Bard Power-Injectable Implantable Ports (PowerPorts®)
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2019-07-08

    (402 days)

    Product Code
    LJT, REQ
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anticancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a Powerloc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
    Device Description
    PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Catheters, included with the port, are pre-attached or may be attached to the port by the physician during implantation. PowerPort® Implantable Ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.
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    K Number
    K151239
    Device Name
    NMI DUAL PORT II
    Manufacturer
    NAVILYST MEDICAL, INC.
    Date Cleared
    2016-06-06

    (392 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K153359
    Device Name
    BardPort®, SlimPort®, and X-Port® Implanted Ports
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2016-05-20

    (182 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BardPort®, SlimPort®, and X-Port® implanted ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
    Device Description
    BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X-Port® Implanted Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation. BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routine vascular access using a non-coring access needle.
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    K Number
    K153238
    Device Name
    Dignity Dual Port
    Manufacturer
    Medcomp ( Medical Components)
    Date Cleared
    2016-03-15

    (127 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Dignity® Dual Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
    Device Description
    The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging. The Dignity® Dual Port will be marketed in four kit configurations, which are listed below: - 9.5F Standard Port Kit (Catalog number MRDP95ADN) - 9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN) - 9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS) - 9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS) The Dignity® Dual Port is comprised of a polysulfone cap (with silicone filled suture holes, or open suture holes), two silicone septa, and a polysulfone base assembly with a titanium tube that provides a channel from the stem to the distal reservoir. The reservoir is plastic (polysulfone). The Dignity® Dual catheter locking assembly (makrolon/pellethane) locks the chronoflex lumen to the plastic stem of the Dignity® Dual Port.
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    K Number
    K153228
    Device Name
    NMI Port, NMI Port II
    Manufacturer
    NAVILYST MEDICAL, INC.
    Date Cleared
    2015-12-04

    (28 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require longterm access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
    Device Description
    The NMI Port and NMI Port II with and without PASV Valve Technology are a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir. The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories. The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.
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    K Number
    K150514
    Device Name
    Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2015-11-20

    (266 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Why did this record match?
    Product Code :

    LJT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
    Device Description
    PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Polyurethane catheters are attached to the port by the physician during implantation. PowerPort® Implantable Ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system. The ChronoFlex® Polyurethane Catheters maintain an average root mean square catheter surface profilometry of less than 0.5µm.
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