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

    CENTRACATH #130,135 & 137-HEMOCATH #

    K Number: K833079 · Decision Dec 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    20
    Review Days
    111

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    Basic Information

    Device Name
    CENTRACATH #130,135 & 137-HEMOCATH #
    K Number
    K833079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Exco, Inc.
    Date Received
    September 9, 1983
    Decision Date
    December 29, 1983
    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 Exco, Inc.

    K Number Device Name
    K844203 ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
    K844175 ENTERNAL FEEDING TUBE-POLYURETHANE EF504
    K844174 FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
    K832628 VYGON THORACIC DRAINAGE-VARIOUS #'S
    K831802 LIFE VAC #2191 & 2192
    K830910 MANOMETER SET C.V.P. #S 298/299
    K822879 ENTERAL NUTRITION 1
    K822691 VYGON EPIDURAL ANAESTHESIA TRAY
    K822836 MICROFLEX-VENOFLUX
    K822724 SUCTION TUBES
    Search all 20 clearances from Exco, Inc. →