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510(k) Data Aggregation

    K Number
    K052075
    Device Name
    PROCEDUR-10
    Manufacturer
    AVANCA MEDICAL DEVICES, INC.
    Date Cleared
    2005-11-09

    (100 days)

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

    AVANCA MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Procedur-10 device is intended to be used to inject fluids into, or withdraw fluids from, the body
    Device Description
    The Procedur-10 device is a piston syringe
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    K Number
    K042486
    Device Name
    PROCEDUR 10 SYRINGE DEVICE
    Manufacturer
    AVANCA MEDICAL DEVICES, INC.
    Date Cleared
    2005-01-21

    (130 days)

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

    AVANCA MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Procedur-10 device is used to inject fluids into, or withdraw fluids from, the body.
    Device Description
    The Procedur-10 device is a piston syringe
    Ask a Question
    K Number
    K042487
    Device Name
    PROCEDUR SF SAFETY SYRINGE DEVICE
    Manufacturer
    AVANCA MEDICAL DEVICES, INC.
    Date Cleared
    2005-01-21

    (130 days)

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

    AVANCA MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Procedur-SF device is used to inject fluids into, or withdraw fluids from, the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
    Device Description
    The Procedur-SF device is a piston safety syringe. The Procedur-SF device utilizes two syringes assembled in a plastic holder. The syringe plungers are connected by a pulley.
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