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

    Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

    K Number: K202176 · Decision Sep 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
    K Number
    K202176
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc. (dba MedComp)
    Date Received
    August 4, 2020
    Decision Date
    September 3, 2020
    Product Code
    MSD
    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
    MSD Catheter, Hemodialysis, 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
    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
    K180567 C3 Wave System
    K170770 CT Midline