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

    MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M

    K Number: K973561 · Decision May 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    63
    Review Days
    234

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    Basic Information

    Device Name
    MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
    K Number
    K973561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Components, Inc.
    Date Received
    September 19, 1997
    Decision Date
    May 11, 1998
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Medical Components, Inc.

    K Number Device Name
    K250836 14F Duo-Flow® Side X Side Double Lumen Catheter
    K141633 PRO-PICC WITH VALVE TECHNOLOGY
    K132880 MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
    K131687 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
    K130687 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
    K130923 5F DIGNITY CT TITANIUM PORT
    K124046 VALVED TEARAWAY INTRODUCER GENERATION II
    K123617 3F PRO-PICC
    K122423 VASU-PICC
    K121848 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
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