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

    APRO 55 Catheter

    K Number: K234115 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    10
    Review Days
    79

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    Basic Information

    Device Name
    APRO 55 Catheter
    K Number
    K234115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alembic, LLC
    Date Received
    December 27, 2023
    Decision Date
    March 15, 2024
    Product Code
    DQY
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DQY Catheter, Percutaneous

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    Other Clearances by Alembic, LLC

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    K243297 APRO 70 Swift Catheter
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