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510(k) Data Aggregation

    K Number
    K051084
    Device Name
    DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
    Manufacturer
    DENVER BIOMEDICALS, INC.
    Date Cleared
    2005-06-13

    (46 days)

    Product Code
    DWM
    Regulation Number
    870.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENVER BIOMEDICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle are indicated for intermittent long term drainage of symptomatic, recurrent pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
    Device Description
    The Pleurx Drainage Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
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    K Number
    K011020
    Device Name
    DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
    Manufacturer
    DENVER BIOMEDICALS, INC.
    Date Cleared
    2001-06-01

    (58 days)

    Product Code
    KPM
    Regulation Number
    876.5955
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENVER BIOMEDICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010642
    Device Name
    PLEURX PLEURAL CATHETER AND DRAINAGE KITS
    Manufacturer
    DENVER BIOMEDICALS, INC.
    Date Cleared
    2001-03-20

    (15 days)

    Product Code
    DWM
    Regulation Number
    870.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENVER BIOMEDICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003451
    Device Name
    DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
    Manufacturer
    DENVER BIOMEDICALS, INC.
    Date Cleared
    2001-01-02

    (56 days)

    Product Code
    KPM
    Regulation Number
    876.5955
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENVER BIOMEDICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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