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510(k) Data Aggregation

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    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
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    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
    K251051
    Device Name
    AuST Steerable Sheath
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2025-04-30

    (27 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
    Device Description
    The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements. The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bi-directional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.
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    K Number
    K243180
    Device Name
    SSPC NXT Delivery Catheter
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2024-12-04

    (65 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    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 (SSPC NXT 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 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
    K242106
    Device Name
    AuST Steerable Sheath
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2024-10-04

    (78 days)

    Product Code
    DYB, DRA
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use this device for neural placements.
    Device Description
    The modified AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements. The modified AuST Steerable Sheath includes a longer catheter shaft, longer dilator, longer hydrophilic coating, modified hemostatic valve, and modified packaging. The modified AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bidirectional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.
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    K Number
    K233752
    Device Name
    Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2024-05-02

    (162 days)

    Product Code
    FBN, FET, NTN, ODC
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dragonfly Pancreaticobiliary Scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Instrument Channel Caps are used to cover the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
    Device Description
    The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for singleoperator per-oral 2holoangiopancreatoscopy. The Dragonfly Pancreaticobiliary System is comprised of two components: The Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller. The Dragonfly Pancreaticobiliary Scope System is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Pancreaticobiliary Scope is a single-use catheter which provides direct visualization with a camera and illumination, and enables access and delivery of accessories to targeted pancreaticobiliary anatomy. The Dragonfly Pancreaticobiliary Scope comprises of a handle, a catheter, imaging and illumination elements, and a video connection mechanism. The Dragonfly Digital Controller is a reusable accessory which controls illumination and receives, processes, and outputs video signals from the Dragonfly Pancreaticobiliary Scope. The system does not treat or diagnosis conditions. The Dragonfly Instrument Channel Caps, which are included in package with the Dragonfly Pancreaticobiliary Scope, are used to cover the opening to the biopsy/suction channel inlet of a Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
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    K Number
    K240829
    Device Name
    AuST Steerable Sheath
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2024-05-01

    (36 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal and other peripheral placements. Do not use for neural placements.
    Device Description
    The AuST Steerable Sheath is a single-use percutaneous catheter intended to provide a pathway through which diagnostic and therapeutic devices are introduced in the human vasculature. The catheter is not intended for neural placements. The AuST Steerable Sheath product family consists of a variety of configurations to accommodate different anatomies and/or devices being introduced into the human vasculature. Each of the sheaths in the product family is comprised of a braid-reinforced catheter shaft, bidirectional deflectable segment, radiopaque distal tip, a handle with a 3-way stopcock for flushing and aspiration, and a hemostasis valve to prevent air and fluid leakage.
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    K Number
    K223097
    Device Name
    RenaNav Ureteroscope System
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2023-07-31

    (304 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
    Device Description
    The RenaNav Ureteroscope System is comprised of a single-use ureteroscope and a multi-use video processing unit (VPU). The RenaNav Single-Use Digital Flexible Ureteroscope is a sterile, single use device and is compatible with the multi-use System Video Processing Unit. The Ureteroscope is used by physicians to access, visualize, and perform procedures in the urinary tract. The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.
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    K Number
    K230363
    Device Name
    CPS Locator 3D Delivery Catheter
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2023-03-09

    (27 days)

    Product Code
    DQY, DOY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    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 Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads. The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.
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    K Number
    K210009
    Device Name
    Guiding Catheter
    Manufacturer
    CenterPoint Systems LLC
    Date Cleared
    2021-11-24

    (324 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CenterPoint Systems LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guiding Catheter is indicated to provide a pathway through which therapeutic devices are introduced. The catheter is intended to be used in the peripheral vascular system.
    Device Description
    The Guiding Catheter is a single-use percutaneous catheter intended to be used in the peripheral vascular system to provide a pathway through which therapeutic devices are introduced. The Guiding Catheter is available in a variety of curves to accommodate various anatomies. The Guiding Catheter is comprised of a braid-reinforced catheter shaft terminating in an atraumatic, radiopaque tip. The device includes a proximal hub with luer fitting for fluid infusion and/or aspiration as well as strain relief. The catheter is a single use disposable device. The Guiding Catheter has an inner diameter of 6F, an outer diameter of 7F, and is compatible with an 0.035" guidewire.
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