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510(k) Data Aggregation

    K Number
    K101729
    Device Name
    NEOWIRE PTA/PTCA GUIDEWIRE
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2010-09-23

    (94 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.
    Device Description
    NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.
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    K Number
    K043398
    Device Name
    MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2005-03-01

    (81 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
    Device Description
    The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.
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    K Number
    K040786
    Device Name
    VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2004-04-19

    (21 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.
    Device Description
    The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.
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    K Number
    K033321
    Device Name
    SELECTIVA SB GUIDEWIRE
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2003-11-05

    (21 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
    Device Description
    The Selectiva SB Guidewires are constructed of a nickel-titanium alloy with a PTFE polymer jacket. Devices are available in a diameter of 0.035 inches and in lengths ranging from 40 to 300 cm.
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    K Number
    K031652
    Device Name
    VASCUPUNCTURE PICC GUIDEWIRE
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2003-09-30

    (125 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.
    Device Description
    The VascuPuncture PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.
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    K Number
    K012861
    Device Name
    VASCUPUNCTURE ACCESS WIRE
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2002-02-05

    (165 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE NEOMETRICS VASCUPUNCTURE ACCESS WIRE IS IN DICATED FOR PERCUTANEOUS VASCULAR ENTRY USING THE SELDINGER TECHNIQUE,
    Device Description
    This guidewire has a 0.0175" diameter and is available in lengths of 45-120 cm. It features gradual diameter changes in the distal section to facilitate vascular insertion and compatibility with various introducers and catheters. A variety of distal tapers impart different tip flexibilities.
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    K Number
    K013024
    Device Name
    SELECTIVA GUIDEWIRE
    Manufacturer
    NEO METRICS, INC.
    Date Cleared
    2001-12-04

    (88 days)

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

    NEO METRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.
    Device Description
    The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.
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