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

    C3 Wave System

    K Number: K180567 · Decision Apr 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    8
    Review Days
    38

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    Basic Information

    Device Name
    C3 Wave System
    K Number
    K180567
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc. (dba MedComp)
    Date Received
    March 5, 2018
    Decision Date
    April 12, 2018
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Medical Components, Inc. (dba MedComp)

    K Number Device Name
    K232945 Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
    K202176 Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
    K192807 Duo-Flow Side x Side Double Lumen Catheter
    K183219 Trio-CT Triple Lumen Catheter
    K181175 12F Tri-Flow Triple Lumen Catheter
    K173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
    K170770 CT Midline