BEUDAMED
    Product Code: QHW FDA class 2 21 CFR 870.4100

    Single Lumen Ecmo Cannula

    Cardiovascular

    The Single Lumen ECMO Cannula is a cardiovascular device consisting of single-lumen cannulas or catheters intended for use with extracorporeal circuits in patients with acute respiratory failure or acute cardiopulmonary failure where other treatments have failed and the risk of death is imminent. It is classified as FDA Class 2, requiring 510(k) clearance, and falls under the Cardiovascular medical specialty, regulated under 21 CFR 870.4100. The product code is QHW. Despite its critical application in life-threatening situations, the device is not formally flagged as life-sustaining in this classification record, and it is not an implant.

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    510(k)s
    3
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    4

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    Basic Information

    Product Code
    QHW
    Device Class
    FDA class 2
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in 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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K251831 Bio-Medicus Life Support Catheter and Introducer
    K240534 Bio-Medicus Life Support Catheter and Introducer
    K201057 Bio-Medicus Life Support Catheter and Introducer

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.