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510(k) Data Aggregation

    K Number
    K222948
    Device Name
    Q Distal Access Catheter
    Manufacturer
    MIVI Neuroscience, Inc
    Date Cleared
    2023-09-19

    (357 days)

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

    MIVI Neuroscience, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
    Device Description
    The Q Distal Access Catheter is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The proximal portion of the device is a stainless-steel control wire. The distal portion of the device is a coiled/braided catheter shaft with hydrophilic coating along the entire length to reduce friction during use. The Q Distal Access Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The pin vise may be used to advance the catheter. The syringe and flush tool components may aid in the flushing of the Q Distal Access Catheter.
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    K Number
    K212402
    Device Name
    MIVI Q Distal Access Catheter
    Manufacturer
    MIVI Neuroscience, Inc.
    Date Cleared
    2021-12-16

    (136 days)

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

    MIVI Neuroscience, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIVI Q Distal Access Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
    Device Description
    The MIVI Q Distal Access Catheter (Q Catheter) is a single-lumen, variable stiffness catheter with radiopaque markers on the distal and proximal end of the catheter portion for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. The proximal portion of the catheter is a stainless-steel control (push) wire. The Q Catheter may be introduced via an 8F guide catheter/6F guide sheath and over a guidewire/microcatheter into the arterial vasculature until the desired vessel is reached. The Q Docking Station may be used to facilitate insertion and extraction of the Q Catheter through a hemostasis valve attached to the 8F guide catheter/6F guide sheath. The pin vise may be used to advance the catheter.
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    K Number
    K163233
    Device Name
    MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
    Manufacturer
    MIVI NEUROSCIENCE, INC
    Date Cleared
    2017-04-06

    (140 days)

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

    MIVI NEUROSCIENCE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIVI Mi-EXT Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
    Device Description
    Not Found
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    K Number
    K151396
    Device Name
    MIVI Mi-AXUS Guide Catheter
    Manufacturer
    MIVI NEUROSCIENCE, INC
    Date Cleared
    2015-12-09

    (197 days)

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

    MIVI NEUROSCIENCE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIVI Mi-Axus™ Guide Catheter is indicated for use in facilitating the insection and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
    Device Description
    The MIVI Mi-Axus 8F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary, or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. Additionally, the distal segment of the PEBAX shaft of the 8F device is impregnated with Barium Sulfate (BaS04) for increased radiopacity. A luer hub on the proximal end allows attachments for flushing, insertion of catheters, and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MIVI Mi-Axus Guide Catheter has a straight distal tip and is available in lengths of 80 or 90 cm and an 8F diameter.
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    K Number
    K151825
    Device Name
    Viradius Neurowire
    Manufacturer
    MIVI NEUROSCIENCE, INC.
    Date Cleared
    2015-11-16

    (133 days)

    Product Code
    MOF, DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIVI NEUROSCIENCE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viradius™ Neurowire is intended for selective placement of catheters within the neuro and peripheral vasculature.
    Device Description
    The Viradius™ Neurowire consists of a stainless steel wire core and a radiopaque platinum/tungsten coil on the distal tip. The distal section of the guidewire is coated with a hydrophilic coating and the proximal portion of the device is coated with a hydrophobic coating. The guidewire is inserted into a polyethylene hoop and then placed along with a torque device into a labeled poly/tyvek pouch and ethylene oxide sterilized. The pouch, along with an Instruction for Use paper insert is placed into a labeled shipping box.
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