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510(k) Data Aggregation

    K Number
    K081713
    Device Name
    VERTEBRAL ACCESS SYSTEM BY VIDACARE
    Manufacturer
    VIDACARE CORPORATION
    Date Cleared
    2008-11-21

    (157 days)

    Product Code
    MOQ, OAR
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    MOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.
    Device Description
    The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.
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    K Number
    K013133
    Device Name
    NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
    Manufacturer
    NORDIX, INC.
    Date Cleared
    2001-11-13

    (55 days)

    Product Code
    MOQ, MOZ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    MOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement Battery for Baxter Flo-Gard Pump 8000, 8100, 8200 Infusion Pumps inidator. Formps This battery is sold only to customers who request a replacement battery for a particular device or to replace a competitor's Dattery for a particular dovice of to a loss equipment technician knows the intended use is as a replacement battery.
    Device Description
    Nordix Rechargeable Battery Part Number 2116
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    K Number
    K980224
    Device Name
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
    Manufacturer
    ALEXANDER MFG. CO.
    Date Cleared
    1998-04-02

    (70 days)

    Product Code
    MOQ
    Regulation Number
    878.4820
    Why did this record match?
    Product Code :

    MOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
    Device Description
    Rechargeable Battery Part Number MS822
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