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

    CT Midline

    K Number: K170770 · Decision Jul 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    133

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CT Midline
    K Number
    K170770
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Components, Inc. (dba MedComp)
    Date Received
    March 14, 2017
    Decision Date
    July 25, 2017
    Product Code
    PND
    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
    PND Midline Catheter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PND), ordered by most recent decision date.

    Midline Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Arrow Pressure Injectable Midline Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Provena(TM) Midline Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Stiletto Extended Dwell Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    primeMidline Catheters

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    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
    K180567 C3 Wave System