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510(k) Data Aggregation

    K Number
    K072255
    Device Name
    MINRAD INC. NASAL SCAVENGING CIRCUIT
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2007-10-18

    (66 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.
    Device Description
    The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.
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    K Number
    K071814
    Device Name
    LIGHT SABRE SPINAL ACCESS DEVICE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2007-10-16

    (106 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.
    Device Description
    The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.
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    K Number
    K062230
    Device Name
    MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2006-08-31

    (29 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    MR Fiber Optic Intubating Laryngoscope Handle, Short
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    K Number
    K062231
    Device Name
    MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2006-08-31

    (29 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    The MR Fiber Optic Intubating Laryngoscope Handle, Standard
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    K Number
    K041852
    Device Name
    MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2004-11-15

    (130 days)

    Product Code
    CCW
    Regulation Number
    868.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.
    Device Description
    Not Found
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    K Number
    K041846
    Device Name
    SABRESOURCE DRAPE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2004-08-26

    (49 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SabreSource™ Drape is intended to help prevent contamination of the SabreSource™ device when used in the operating room or other surgical environments. The SabreSource™ Drape is to be used in an operating room environment to cover the SabreSource™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the SabreSource™ device from contamination with patient fluids or liquids.
    Device Description
    The SabreSource™ Drape is a sterile plastic bag to cover the SabreSource™ Targeting System. The drape contains an optically clear window shaped like a section of a hemisphere with a 30 cm radius that will allow undistorted transmission of the laser beam from the SabreSource™ to the patient.
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    K Number
    K021084
    Device Name
    LIGHT SABER SPINAL NEEDLE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2002-07-03

    (90 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A single use disposable spinal needle/cannula intended for the injection of fluids into or retraction of fluids from the body. A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.
    Device Description
    The Light Saber™ Spinal Needle consists of a needle and a collimator to which a stylet is attached. The stylet is enclosed in a cannula/hub assembly with a matching tip. The female Luer of the cannula hub, for the attachment to the syringe, is designed to comply with ISO-594 for "Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Other Medical Equipment." The Light Saber™ Spinal Needles are provided in gauges of 18, 20, 22, 23, and 25. The Light Saber™ Spinal Needle will be provided in lengths of 3.75, 6.25, 8.75, 15 and 20 cm. The tip design for these needles will provide either a Quincke, Short Bevel or Chiba point. Depth markings are standard on the cannula.
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    K Number
    K013040
    Device Name
    LIGHT SABER INTRODUCER NEEDLE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    2001-12-07

    (88 days)

    Product Code
    MDM, FMF
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures. Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
    Device Description
    The Light Saber Introducer Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals.
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    K Number
    K982735
    Device Name
    LIGHT SABER BONE BIOPSY NEEDLE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    1998-09-09

    (35 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable needle for obtaining biopsies from Bone and Bone Marrow.
    Device Description
    Not Found
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    K Number
    K982018
    Device Name
    LIGHT SABER ASPIRATION NEEDLE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    1998-08-07

    (60 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MINRAD, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single use disposable aspiration needle to attach to a syringe to inject fluids into, or retract fluids from the body
    Device Description
    Not Found
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