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

    ClearGuard HD Antimicrobial Barrier Cap

    K Number: K180111 · Decision May 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    129

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    Basic Information

    Device Name
    ClearGuard HD Antimicrobial Barrier Cap
    K Number
    K180111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pursuit Vascular, Inc.
    Date Received
    January 16, 2018
    Decision Date
    May 25, 2018
    Product Code
    PEH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PEH Hemodialysis Catheter Luer End Cap

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    Other Clearances by Pursuit Vascular, Inc.

    K Number Device Name
    K131060 CLEARGUARD HD END CAP