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510(k) Data Aggregation

    K Number
    K232662
    Device Name
    BNLE Hydrophilic Jacketed Peripheral Guidewire
    Manufacturer
    Biomerics NLE
    Date Cleared
    2024-05-14

    (257 days)

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

    Biomerics NLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.
    Device Description
    The BNLE Hydrophilic Jacketed Peripheral Guidewire is available in 150 cm - 260 cm lengths and in 0.018" - 0.035" diameter ranges. The hydrophilic coated guidewire consists of a nickel-titanium alloy core wire and tungsten infused polyurethane jacket in configurations of wire stiffness and tip shape. The finished guidewire is placed in a dispenser hoop and Tyvek pouch. Five (5) Tyvek pouches are placed into a shelf box with an IFU, and 26 shelf cartons are placed into a shipper box. Labels are placed on the Tyvek pouch and shelf box. The finished product is EO sterilized.
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    K Number
    K221390
    Device Name
    BNLE Access Guidewire
    Manufacturer
    Biomerics NLE
    Date Cleared
    2023-04-28

    (350 days)

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

    Biomerics NLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.
    Device Description
    The BNLE Access Guidewires are available in 40 cm to 80 cm lengths and in the 0.018" – 0.021" diameter range. The BNLE Access Guidewires are available with Nitinol or Stainless Steel (SS) shafts and in configurations with SS coils or radiopaque Tungsten coils. The BNLE Access Guidewires consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A micro-coil is wound with a lumen that is then placed over the tapered distal section. The distal end is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The micro-coil will provide tip radiopacity in designated models. The finished guidewire is placed in a protective polymer dispenser hoop for either sterile packaging in a labeled Tyvek pouch or shipped in bulk non-sterile condition to use with in a procedure tray by a customer.
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    K Number
    K190259
    Device Name
    Vesta RF Cannula
    Manufacturer
    Biomerics
    Date Cleared
    2020-02-07

    (365 days)

    Product Code
    GXI, VES
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    Biomerics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
    Device Description
    The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.
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    K Number
    K121773
    Device Name
    NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
    Manufacturer
    BIOMERICS
    Date Cleared
    2012-09-21

    (95 days)

    Product Code
    GXI, BAS
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMERICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.
    Device Description
    The NIMBUS Electrosurgical Radiofrequency Mutitined Expandable Electrode consists of an insulated cannula with an active tip that directs RF energy into target tissues, and a pair of deployable tines which expand the volume of the ablation. It is intended, in combination with an RF generator and probe, for use in radiofrequency (RF) heat lesion procedures for relief of pain.
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