Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K240534
    Device Name
    Bio-Medicus Life Support Catheter and Introducer
    Manufacturer
    Medtronic Inc.
    Date Cleared
    2024-04-19

    (53 days)

    Product Code
    QHW, DWF
    Regulation Number
    870.4100
    Why did this record match?
    Product Code :

    QHW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cardiopulmonary Bypass (CPB): Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours. Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS): The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure. where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
    Device Description
    The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters. These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25℃ (77°F).
    Ask a Question
    K Number
    K201057
    Device Name
    Bio-Medicus Life Support Catheter and Introducer
    Manufacturer
    Medtronic Inc.
    Date Cleared
    2022-01-14

    (633 days)

    Product Code
    QHW, OHW
    Regulation Number
    870.4100
    Why did this record match?
    Product Code :

    QHW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
    Device Description
    The Bio-Medicus Life Support™ catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters. These devices are sterile, nonpyrogenic, disposable, intended for single use only. Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. Do not store the product above 25°C (77°F).
    Ask a Question

    Page 1 of 1