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

    SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II

    K Number: K883054 · Decision Sep 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    109
    Review Days
    69

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    Basic Information

    Device Name
    SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
    K Number
    K883054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Scimed Life Systems, Inc.
    Date Received
    July 19, 1988
    Decision Date
    September 26, 1988
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Scimed Life Systems, Inc.

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    K974559 SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
    K974684 SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
    K973945 LUGE GUIDE WIRE
    K970823 SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
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    K965023 CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
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