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510(k) Data Aggregation

    K Number
    K152560
    Device Name
    Bard Snare Retrieval Kit
    Manufacturer
    NEOMETRICS, INC
    Date Cleared
    2015-10-23

    (44 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.
    Device Description
    The Bard® Snare Retrieval Kit is intended to percutaneously remove Bard filters from the vena cava. The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6 French Snare Catheter Assembly and a 11 French O.D Retrieval Sheath with 9 French Dilator Assembly. The nitinol snare has a 20 mm diameter (fully expanded) radiopaque loop and comes preloaded in the snare catheter. The snare catheter, retrieval sheath, and access sheath have radiopaque marker bands at the distal ends for enhanced fluoroscopic visualization.
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    K Number
    K150225
    Device Name
    NovaGold High Performance Guidewire
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2015-03-16

    (42 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaGold Guidewire is intended for use in selective cannulation of the billary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic devices during endoscopic procedures.
    Device Description
    The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
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    K Number
    K143135
    Device Name
    Spring Coil Guidewire
    Manufacturer
    NeoMetrics, Inc.
    Date Cleared
    2015-02-20

    (112 days)

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

    NeoMetrics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the placement of devices during diagnostic or interventional procedures.
    Device Description
    NeoMetrics guidewires are constructed using stainless steel and nickel titanium alloys. Configurations include a single tip or dual tip, retracted core or fixed core, and straight or J-tipped. The guidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewire into the puncture needle.
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    K Number
    K133076
    Device Name
    NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2014-02-20

    (143 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
    Device Description
    The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
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    K Number
    K123439
    Device Name
    NEO ERCP GUIDEWIRE
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2013-01-03

    (56 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo ERCP Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
    Device Description
    The Neo ERCP Guidewire is constructed of a core wire of nickel titanium based alloy, a proximal polymer jacket and a radiopaque distal tip. It also features a hydrophilic coating and either straight or angled distal tip configurations. The distal end of the guidewire has a radiopaque distal tip (10cm). The wire family has two models, the Phantom refers to .025" OD models and the Palomino refers to .035" OD models. Both the Phantom and Palomino come in 260cm and 480cm lengths.
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    K Number
    K070150
    Device Name
    VASCUPUNCTURE PICC GUIDEWIRE
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2007-02-15

    (30 days)

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

    NEOMETRICS, 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. The device is 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 or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.
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    K Number
    K001455
    Device Name
    ACCUWELL TSH, MODEL KAW-TSH-960
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    2000-11-02

    (177 days)

    Product Code
    JLW
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991498
    Device Name
    ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    1999-06-16

    (48 days)

    Product Code
    JIA
    Regulation Number
    862.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neometrics' ACCUWELL™ Total Galactose kits are intended to be used for the quantitative measurment of Total Galactose in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newborns for galactosemia.
    Device Description
    Not Found
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    K Number
    K974047
    Device Name
    ACCUWELL PHENYLALANINE ASSAY
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    1997-12-05

    (42 days)

    Product Code
    JNB
    Regulation Number
    862.1555
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neometrics' ACCUWELL™ Phenylalanine kits are intended to be used for the quantitative measurement of phenylalanine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen for phenylketonuria disease.
    Device Description
    Not Found
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    K Number
    K972974
    Device Name
    ACCUWELL T4-EIA
    Manufacturer
    NEOMETRICS, INC.
    Date Cleared
    1997-10-06

    (56 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOMETRICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neometrics' Accuwell™ T4 EIA kits are intended to be used for the quantitative measurement of Thyroxine in neonatal dried blood spot samples which have been collected onto S&S grade 903 filter paper. Results are used to screen newboros for congenital hypothyroidism.
    Device Description
    Not Found
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