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510(k) Data Aggregation

    K Number
    K201487
    Device Name
    Traxcess 7 Mini Guidewire
    Manufacturer
    Micro Vention Inc.
    Date Cleared
    2020-07-02

    (28 days)

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

    Micro Vention Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Traxcess™ 7 Mini Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not indicated for use in coronary arteries.
    Device Description
    Traxcess™ 7 Mini Guidewire consists of a proximal coated 0.014" stainless steel core wire, and a distal coated 0.007" nitinol core wire. The distal core wire is tapered at the distal tip and is contained within platinum/nickel coil. The platinum/nickel coil is 6 cm in length. The distal 1.4 cm of the guidewire is shapeable by the physician. Traxcess™ 7 Mini Guidewire distal and proximal sections are coated with hydrophilic coating. There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.
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    K Number
    K182602
    Device Name
    SOFIA EX Intracranial Support Catheter
    Manufacturer
    Micro Vention Inc.
    Date Cleared
    2019-05-15

    (236 days)

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

    Micro Vention Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.
    Device Description
    The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box.
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