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

    12F Tri-Flow Triple Lumen Catheter

    K Number: K181175 · Decision Jul 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    12F Tri-Flow Triple Lumen Catheter
    K Number
    K181175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc. (dba MedComp)
    Date Received
    May 2, 2018
    Decision Date
    July 5, 2018
    Product Code
    NIE
    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
    NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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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
    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
    K180567 C3 Wave System
    K170770 CT Midline