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

    APRO 70 Swift Catheter and Alembic Aspiration Tubing

    K Number: K243287 · Decision Feb 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    10
    Review Days
    129

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    Basic Information

    Device Name
    APRO 70 Swift Catheter and Alembic Aspiration Tubing
    K Number
    K243287
    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
    October 18, 2024
    Decision Date
    February 24, 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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    Other Clearances by Alembic, LLC

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    K250958 APRO 55 Swift Catheter and Alembic Aspiration Tubing
    K243297 APRO 70 Swift Catheter
    K234115 APRO 55 Catheter
    K232971 APRO 55 Catheter and Alembic Aspiration Tubing
    K230695 APRO 70 Catheter and Alembic Aspiration Tubing
    K223545 APRO 70 Catheter and Alembic Aspiration Tubing