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

    XplantR Explant Tool

    K Number: DEN250033 · Decision Apr 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    253

    Basic Information

    Device Name
    XplantR Explant Tool
    K Number
    DEN250033
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.4520
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Hjarta Care, LLC
    Date Received
    August 7, 2025
    Decision Date
    April 17, 2026
    Product Code
    SHR
    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
    SHR Device For Open Surgical Explant Of Endovascular Prostheses