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510(k) Data Aggregation

    K Number
    K250972
    Device Name
    Primum Hydrophilic Guiding Catheter
    Manufacturer
    PendraCare
    Date Cleared
    2025-06-29

    (90 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guiding Catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced. The Guiding Catheter is intended to be used in the coronary or peripheral vascular system.
    Device Description
    The Hydrophilic Guiding Catheter consists of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The (distal part of the) catheter body is provided either with or without "in-line" side holes. The guiding catheter is a flexible plastic tube featuring a luer hub, strain relief, a body, an intermediate tip, and a soft tip. The body and the intermediate tip consist of an inner liner (basecoat) and an outer jacket (topcoat) reinforced with a tightly wound stainless steel braid wire in between the layers. The central lumen of the catheter is used for the percutaneous, transluminal passage and placement of guidewires, diagnostic and therapeutic devices within the vascular system. After the catheter is inserted through the skin using a dilator, a sheath (introducer) and guide wire is brought into position. Subsequently, a guidewire is advanced through its lumen and tracked over by a diagnostic device and/or a therapeutic devices to the intended location. The distal section of the catheters has a variety of preformed shapes (e.g. Judkins Left (abbreviated as JL), Judkins Right (JR), Amplatz (AL), Multi-purpose (MP), hockey stick) to facilitate placement of the catheter tip in the desired target vessel. Some catheter models feature two (2) small "in-line" side holes in the intermediate tip section to maintain perfusion of the target vessel. This device is a single-use device (i.e., single patient, single procedure, single purpose use). After finalizing the procedure, the catheter is withdrawn, removed and discarded.
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    K Number
    K250828
    Device Name
    CPS Locator 3D Plus Delivery Catheter
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2025-06-27

    (100 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
    Device Description
    The modified Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter indicated for the introduction of various types of catheters and pacing or defibrillation leads. The modified Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
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    K Number
    K243184
    Device Name
    SAT CenterFlow Molding Balloon Catheter (IN20-00313)
    Manufacturer
    Strait Access Technologies Holdings
    Date Cleared
    2025-06-25

    (268 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
    Device Description
    The CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. When used in its indications for use, it is a low-permissive, over-the-wire, single-use device comprised of two elongated non-compliant nylon balloons that are attached to and within a nitinol support frame. The two elongated balloons are constrained in a zigzag arrangement by the nitinol support frame. Upon inflation, this configuration enables expansion of the device head through balloon straightening, to assist the dilatation of self-expanding endoprostheses in large diameter vessels. Expansion of the zig-zag balloon configuration creates a central orifice permitting maintained hemodynamic flow during the molding procedure. The inflation lumen is 9 Fr and is made of PEBAX 72D. A co-axial PEBAX 72D guidewire lumen runs through the inflation lumen and device head and terminates into a distal polycarbonate tip. Two platinum-iridium markers provide angiographic visualization of the distal and proximal balloon edges to facilitate intravascular balloon placement prior to inflation. The catheter has a working length of 110 cm and it connects proximally to a standard Y-connector at the proximal end. The Y-connector allows for separation of two lumens - an angled luer-lock hub to inflate and deflate the balloon and a straight luer-lock hub which accepts a 0.035" guidewire. The device is deflated and inserted over the guidewire through the hemostasis valve of a transfemoral introducer sheath.
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    K Number
    K251240
    Device Name
    Branchor X Balloon Guide Catheter
    Manufacturer
    Asahi Intecc Co., Ltd.
    Date Cleared
    2025-06-20

    (59 days)

    Product Code
    QJP
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media. The balloon provides temporary vascular occlusion during these procedures. The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.
    Device Description
    The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label. The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section. The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.
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    K Number
    K251560
    Device Name
    FUBUKI XF-R Neurovascular Long Sheath
    Manufacturer
    Asahi Intecc Co., Ltd.
    Date Cleared
    2025-06-20

    (30 days)

    Product Code
    QJP
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUBUKI XF-R Neurovascular Long Sheath is intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the neurovasculature. The FUBUKI XF-R Neurovascular Long Sheath is also intended to be used for injection of contrast media. The FUBUKI XF-R Neurovascular Long Sheath is intended for use only in the neurovasculature.
    Device Description
    The FUBUKI XF-R Neurovascular Long Sheath (FUBUKI XF-R) consists of a long sheath and a dilator. The long sheath is a single lumen neurovascular catheter designed for introduction of interventional devices, such as guidewires and other therapeutic devices. The long sheath consists of three sections: (1) a shaft, (2) a protector and (3) a connector. The distal portion of the shaft consists of a soft tip and a soft tube. The proximal part of the shaft is covered by the protector (strain relief) and the connector is bonded to the proximal end of the shaft. The subject device is provided sterile, by ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures. The outer surface of the long sheath is coated with a hydrophilic polymer and the inner lumen of the shaft (excluding the connector portion) is lined with a fluoropolymer layer to facilitate movement of the guidewire and other devices. The dilator consists of two parts: (1) a shaft and (2) a connector. The FUBUKI XF-R is supplied with a dilator and rotating hemostasis valve (RHV) packed in a sterile package.
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    K Number
    K250492
    Device Name
    FlexiGo 3D Delivery Catheter
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2025-06-18

    (118 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.
    Device Description
    The modified Delivery Catheter (FlexiGo 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads. The modified Delivery Catheter is packaged with a dilator and two (2) trans vavular introducers for introduction into the vasculature. Proximally, the modified Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The modified Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. A variety of curves and lengths are available to accommodate various anatomies and different locations.
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    K Number
    K250219
    Device Name
    Dorado™ PTA Balloon Dilatation Catheter
    Manufacturer
    Bard Peripheral Vascular, Inc.
    Date Cleared
    2025-06-17

    (144 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.
    Device Description
    The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.
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    K Number
    K243948
    Device Name
    Raptor Aspiration Catheter; Balt Aspiration Tubing Set
    Manufacturer
    Balt USA, LLC
    Date Cleared
    2025-06-03

    (162 days)

    Product Code
    NRY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raptor Aspiration Catheter: The Raptor Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Balt Aspiration Tubing Set: The Balt Aspiration Tubing Set is intended to connect the Raptor Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
    Device Description
    The Raptor Aspiration Catheter is a single-lumen, variable stiffness composite catheter offered in various sizes that facilitates removal of thrombus from the neurovasculature when connected to a compatible aspiration pump and the Balt Aspiration Tubing Set. The distal tip of the catheter shaft includes a markerband and the proximal end of the catheter has a luer fitting to allow for the attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter. The Raptor Aspiration Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Raptor Aspiration Catheters are compatible with 0.014" – 0.018" guidewires. A peelable split Introducer Sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Raptor Aspiration Catheter into an appropriate vascular sheath. The catheter and Introducer Sheath are provided sterile, non-pyrogenic, and intended for single use only. The Balt Aspiration Tubing Set consists of one 100" HPF proximal tubing with a suction connector on one end and male rotator on the other, one 1-way Large Bore Stopcock, and one 10" HPF distal tubing with a female luer connector on one end and a male rotator on the other. The Balt Aspiration Tubing Set facilitates the supply of vacuum from a compatible aspiration pump to the distal tip of the Raptor Aspiration Catheter. Balt Aspiration Tubing Set is provided sterile, non-pyrogenic and it is intended for single use only.
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    K Number
    K250410
    Device Name
    GORE® Tri-Lobe Balloon Catheter
    Manufacturer
    W. L. Gore & Associates, Inc.
    Date Cleared
    2025-06-02

    (109 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.
    Device Description
    The GORE® Tri-Lobe Balloon Catheter is a compliant, tri-lobed polyurethane balloon catheter. The lobed design of the balloon catheter is designed for inflation without complete blockage of aortic blood flow. The three polyurethane balloons are mounted on the leading end of a multi-lumen catheter shaft. Radiopaque markers indicate the balloon edges. Each of the three inflation lumens is in communication with one of the balloons. The inflation port is in communication with all of the inflation lumens and is affixed with a luer lock. The guidewire lumen allows introduction of a 0.035" (0.89 mm) diameter guidewire for over-the-wire access. The trailing end of the guidewire lumen is affixed with a flushing/guidewire port with a luer lock, used for flushing the guidewire lumen. A Tuohy-Borst valve is integrated into the trailing end of the guidewire lumen. The GORE® Tri-Lobe Balloon Catheter is available in two sizes. The smaller balloon can be inflated to diameters of 16 mm to 32 mm and the larger balloon can be inflated to diameters of 26 mm to 48 mm.
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    K Number
    K251376
    Device Name
    LimFlow ARC
    Manufacturer
    LimFlow Inc.
    Date Cleared
    2025-05-31

    (29 days)

    Product Code
    PDU
    Regulation Number
    870.1250
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LimFlow ARC is intended to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The LimFlow ARC is a single-use device designed to facilitate placement and positioning of guide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.
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