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

    MEDCOMP FEMORAL VEIN CATHETER

    K Number: K801967 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    63
    Review Days
    38

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    Basic Information

    Device Name
    MEDCOMP FEMORAL VEIN CATHETER
    K Number
    K801967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Components, Inc.
    Date Received
    August 19, 1980
    Decision Date
    September 26, 1980
    Product Code
    FIF
    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
    FIF Set, Dialysis, Single Needle With Uni-Directional Pump

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    Other Clearances by Medical Components, Inc.

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    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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