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

    Duo-Flow Side x Side Double Lumen Catheter

    K Number: K192807 · Decision Apr 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    8
    Review Days
    205

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    Basic Information

    Device Name
    Duo-Flow Side x Side Double Lumen Catheter
    K Number
    K192807
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc. (dba MedComp)
    Date Received
    October 1, 2019
    Decision Date
    April 23, 2020
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, 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
    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
    K180567 C3 Wave System
    K170770 CT Midline