LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K051985
    Device Name
    BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
    Manufacturer
    BIOVALVE TECHNOLOGIES, INC.
    Date Cleared
    2005-08-17

    (26 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVALVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patient authorized by their physicians to self inject at home.
    Device Description
    The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This nonelectrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body.
    Ask a Question
    K Number
    K050971
    Device Name
    BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
    Manufacturer
    BIOVALVE TECHNOLOGIES, INC.
    Date Cleared
    2005-08-16

    (120 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVALVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioValve Insulin Delivery System (BIDS) is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
    Device Description
    BioValve Technologies proposes to market a disposable pump for the basal and bolus delivery of insulin.
    Ask a Question
    K Number
    K032976
    Device Name
    BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
    Manufacturer
    BIOVALVE TECHNOLOGIES, INC.
    Date Cleared
    2004-04-16

    (205 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVALVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physicians to self inject at home.
    Device Description
    The Mini-Ject is a sterile, single use medical device. The Mini-Ject delivers 0.5ml subcutaneously. The device consists of an injector and a luer adapter to provide a means of filling the device using a standard slip lock syringe. The device is powered by a proprietary charge system wholly contained in the distal portion of the device.
    Ask a Question

    Page 1 of 1