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510(k) Data Aggregation

    K Number
    K151877
    Device Name
    MicroTract Access System
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2015-08-07

    (29 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroTract Access System is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.
    Device Description
    The MicroTract Access System contains a 20 gauge Access Needle, a 0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.
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    K Number
    K140871
    Device Name
    AXERA 2 ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2014-06-06

    (63 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K140287
    Device Name
    AXERA RX ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2014-05-16

    (100 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA RX is a device that is comprised of a flexible tip, anchor mechanism, shaft and handle with control features.
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    K Number
    K140201
    Device Name
    AXERA 2 ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2014-03-28

    (60 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K132263
    Device Name
    AXERA 2 ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2013-08-19

    (28 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA 2 is a device that is comprised of a Latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K123618
    Device Name
    AXERA 2 ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2013-03-24

    (121 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K123135
    Device Name
    AXERA 2 ACCESS SYSTEM MODEL AXE200
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2013-01-28

    (115 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K121521
    Device Name
    AXERA ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2012-06-21

    (29 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K113110
    Device Name
    AXERA ACCESS SYSTEM
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2011-11-09

    (20 days)

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

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXERA Access System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
    Device Description
    The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
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    K Number
    K103421
    Device Name
    ARSTASIS DILATOR ADAPTER
    Manufacturer
    ARSTASIS, INC.
    Date Cleared
    2011-05-24

    (183 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARSTASIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Adapter is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length. The Adapter is intended to allow the use of a .018" guidewire with a 0.035" or 0.038" guidewire compatible dilator up to 23 cm in overall length and to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
    Device Description
    The Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters. The Dilator Adapter is a polyethylene bump extrusion that fits into a .035"-.038" compatible vessel dilator with an internal diameter-sized-- to an .018" guidewire.
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