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

    PiccGuard

    K Number: K191195 · Decision Jan 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    245

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PiccGuard
    K Number
    K191195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Piccguard, LLC
    Date Received
    May 3, 2019
    Decision Date
    January 3, 2020
    Product Code
    PZW
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZW Catheter Access Cover, Tamper-Resistant

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PZW), ordered by most recent decision date.

    3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all