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510(k) Data Aggregation

    K Number
    K230319
    Device Name
    Passio Pump Drainage System
    Manufacturer
    Bearpac Medical
    Date Cleared
    2023-11-24

    (291 days)

    Product Code
    PNG
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bearpac Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
    Device Description
    Not Found
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    K Number
    K201404
    Device Name
    Passio Pump Drainage System
    Manufacturer
    Bearpac Medical
    Date Cleared
    2020-11-20

    (176 days)

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

    Bearpac Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Passio Pump Drainage System is intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnes and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
    Device Description
    Not Found
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    K Number
    K190292
    Device Name
    Passio Pump Drainage System
    Manufacturer
    Bearpac Medical
    Date Cleared
    2019-07-25

    (164 days)

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

    Bearpac Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
    Device Description
    Not Found
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