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510(k) Data Aggregation

    K Number
    K992015
    Device Name
    FREEDOM INFUSION SYSTEM
    Manufacturer
    NOVACON CORP.
    Date Cleared
    1999-09-10

    (87 days)

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

    NOVACON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) Freedom™ is intended to provide continuous infusion of a local anesthetic I rectly into the intraoperative site for postoperative pain management. 2) Freedom™is intended to deliver pain medication percutaneously via a catheter attached to the pump. 3) Freedom™is a single use only device. 4) Freedom™is intended for use as an ambulatory device and is intended for, but limited to, use in the home environment. 5) Freedom™is not intended for epidural, subcutaneous, or vascular drug delivery. 6) Freedom™is not intended for use with chemotherapy drugs. 7) Freedom™is not intended for use with blood, blood products, or TPN.
    Device Description
    The Freedom™ Infusion System pump will conform to the AMMI Draft Infusion Device Standard. The intended use of the Freedom™ Infusion System is identical to the legally marketed PainBuster system.
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    K Number
    K955849
    Device Name
    DIB INFUSOR
    Manufacturer
    NOVACON CORP.
    Date Cleared
    1996-08-05

    (222 days)

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

    NOVACON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the DIB Infusor is similar to that of other legally marketed elastomeric infusion pumps.
    Device Description
    The DIB Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon.
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    K Number
    K960318
    Device Name
    DIB INFUSOR-RA
    Manufacturer
    NOVACON CORP.
    Date Cleared
    1996-08-05

    (195 days)

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

    NOVACON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the DIB-RA Infusor is similar to that of other legally marketed elastomeric infusion pumps.
    Device Description
    The DIB-RA Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon.
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