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

    APRO 55 Swift Catheter and Alembic Aspiration Tubing

    K Number: K250958 · Decision Apr 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    96
    Applicant Total
    10
    Review Days
    28

    Basic Information

    Device Name
    APRO 55 Swift Catheter and Alembic Aspiration Tubing
    K Number
    K250958
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alembic, LLC
    Date Received
    March 31, 2025
    Decision Date
    April 28, 2025
    Product Code
    NRY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRY Catheter, Thrombus Retriever

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