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510(k) Data Aggregation

    K Number
    DEN240048
    Device Name
    Spur Peripheral Retrievable Stent System
    Manufacturer
    Reflow Medical, Inc.
    Date Cleared
    2025-05-29

    (251 days)

    Product Code
    SEU
    Regulation Number
    870.5110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Reflow Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K233350
    Device Name
    SINC Support Catheter
    Manufacturer
    Reflow Medical, Inc.
    Date Cleared
    2024-02-08

    (132 days)

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

    Reflow Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SINC Support Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices, and provide a conduit for delivery of saline solutions or diagnostic/ therapeutics agents.
    Device Description
    The SINC™ (Selective Interventional Navigation Catheter) Support Catheters are single lumen catheters designed to access peripheral vasculature. These catheters are available in a variety of lengths and offer a side port. Each configuration has a braided support matrix and hydrophilic coating on the distal segment of the catheter. The distal tip is clearly distinguished by a radiopaque gold coated tip. The SINC Support Catheters will also allow for exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
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    K Number
    K210188
    Device Name
    coraCross
    Manufacturer
    Reflow Medical
    Date Cleared
    2021-05-28

    (123 days)

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

    Reflow Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewire and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic contrast.
    Device Description
    The coraCross Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.
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    K Number
    K201811
    Device Name
    coraForce and coraFlex Support Catheters
    Manufacturer
    Reflow Medical, Inc.
    Date Cleared
    2020-10-26

    (117 days)

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

    Reflow Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.
    Device Description
    The coraForce and coraFlex Support Catheters are devices intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature. The device consists of a support catheter body with a luer end and a polymer tip (coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.
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    K Number
    K200094
    Device Name
    speX LP Support Catheter
    Manufacturer
    Reflow Medical
    Date Cleared
    2020-03-18

    (62 days)

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

    Reflow Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
    Device Description
    The speX LP Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
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    K Number
    K193596
    Device Name
    Wingman 14, Wingman 14C, Wingman 18, Wingman 35
    Manufacturer
    Reflow Medical
    Date Cleared
    2020-02-20

    (59 days)

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

    Reflow Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wingman Crossing Catheters (14/14C/18/3) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents. The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents. The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.
    Device Description
    The Wingman Crossing Catheter (14/18/35) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The Wingman Crossing Catheter (14C) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the coronary vasculature and peripheral vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
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    K Number
    K193012
    Device Name
    speX Support Catheter
    Manufacturer
    ReFlow Medical
    Date Cleared
    2020-02-19

    (113 days)

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

    ReFlow Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
    Device Description
    The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
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    K Number
    K190393
    Device Name
    Wingman 14C Crossing Catheter
    Manufacturer
    ReFlow Medical, Inc.
    Date Cleared
    2019-05-09

    (79 days)

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

    ReFlow Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.
    Device Description
    The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
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    K Number
    K173661
    Device Name
    Wingman 35 Crossing Catheter
    Manufacturer
    ReFlow Medical, Inc.
    Date Cleared
    2018-04-18

    (140 days)

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

    ReFlow Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
    Device Description
    The Wingman 35 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
    Ask a Question
    K Number
    K173662
    Device Name
    speX Support Catheter
    Manufacturer
    ReFlow Medical, Inc.
    Date Cleared
    2017-12-20

    (21 days)

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

    ReFlow Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
    Device Description
    The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
    Ask a Question

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