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510(k) Data Aggregation

    K Number
    K251831

    Validate with FDA (Live)

    Device Name
    Bio-Medicus Life Support Catheter and Introducer
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-01-15

    (216 days)

    Product Code
    QHW
    Regulation Number
    870.4100
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    0 - 150
    Reference & Predicate Devices
    K203409,K201057,K201100
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K203409

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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°C (77°F).

    Extracorporeal membrane oxygenation (ECMO): Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability.

    AI/ML Overview

    N/A

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