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

    CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)

    K Number: K120677 · Decision Mar 15, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    399
    Applicant Total
    6
    Review Days
    9

    Basic Information

    Device Name
    CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
    K Number
    K120677
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TRIREME MEDICAL INC
    Date Received
    March 6, 2012
    Decision Date
    March 15, 2012
    Product Code
    LIT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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    Other Clearances by TRIREME MEDICAL INC

    K Number Device Name
    K133633 CHOCOLATE PTCA BOLLOON CATHETER
    K122070 CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
    K111544 GLIDER PTCA BALLOON CATHETER
    K101062 GLIDER PTA BALLOON CATHETER
    K094019 GLIDER PTA BALLOON CATHETER