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

    Arrow Stiffening Stylet

    K Number: K220280 · Decision Aug 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    27
    Applicant Total
    4
    Review Days
    210

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    Basic Information

    Device Name
    Arrow Stiffening Stylet
    K Number
    K220280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International, LLC (A subsidiary of Teleflex, Inc.)
    Date Received
    February 1, 2022
    Decision Date
    August 30, 2022
    Product Code
    DRB
    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
    DRB Stylet, Catheter

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