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

    LEADER-CATH

    K Number: K813142 · Decision Nov 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    20
    Review Days
    22

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    Basic Information

    Device Name
    LEADER-CATH
    K Number
    K813142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Exco, Inc.
    Date Received
    November 5, 1981
    Decision Date
    November 27, 1981
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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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
    K833079 CENTRACATH #130,135 & 137-HEMOCATH #
    K830910 MANOMETER SET C.V.P. #S 298/299
    K822879 ENTERAL NUTRITION 1
    K822691 VYGON EPIDURAL ANAESTHESIA TRAY
    K822836 MICROFLEX-VENOFLUX
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