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

    AuST Steerable Sheath

    K Number: K251051 · Decision Apr 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    268
    Registration Numbers
    268
    Same Product Code
    682
    Applicant Total
    10
    Review Days
    27

    Basic Information

    Device Name
    AuST Steerable Sheath
    K Number
    K251051
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CenterPoint Systems LLC
    Date Received
    April 3, 2025
    Decision Date
    April 30, 2025
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by CenterPoint Systems LLC

    K Number Device Name
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    K230363 CPS Locator 3D Delivery Catheter
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