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

    PhasTIPP

    K Number: K212894 · Decision Mar 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    7
    Applicant Total
    32
    Review Days
    202

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    Basic Information

    Device Name
    PhasTIPP
    K Number
    K212894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4885
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LeMaitre Vascular, Inc.
    Date Received
    September 10, 2021
    Decision Date
    March 31, 2022
    Product Code
    DWQ
    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
    DWQ Stripper, Vein, External

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