BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Aspira Pleural Drainage System

    K Number: K212696 · Decision Mar 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    18
    Applicant Total
    178
    Review Days
    555

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    Basic Information

    Device Name
    Aspira Pleural Drainage System
    K Number
    K212696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    August 25, 2021
    Decision Date
    March 3, 2023
    Product Code
    DWM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWM Apparatus, Suction, Patient Care

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