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

    Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

    K Number: K250545 · Decision Jun 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    23
    Review Days
    100

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
    K Number
    K250545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings, Inc.
    Date Received
    February 25, 2025
    Decision Date
    June 5, 2025
    Product Code
    OWQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OWQ Reprocessed Intravascular Ultrasound Catheter

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