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

    SHOOCIN INTRODUCER KIT

    K Number: K123475 · Decision Feb 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    7
    Review Days
    447

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    Basic Information

    Device Name
    SHOOCIN INTRODUCER KIT
    K Number
    K123475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lepu Medical Technology (Beijing) Co., Ltd.
    Date Received
    November 13, 2012
    Decision Date
    February 3, 2014
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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    Other Clearances by Lepu Medical Technology (Beijing) Co., Ltd.

    K Number Device Name
    K172331 Type I, Type II, Type III, Type IV
    K172099 Shoocin Introducer Kit
    K141707 ULTRASKIN HYDROPHILIC GUIDE WIRE
    K142359 Vasc Band hemostat
    K123473 HOPER PTCA BALLOON CATHETER
    K111837 RADIAL ARTERY COMPRESSION TOURNIQUET