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510(k) Data Aggregation

    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
    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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