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

    MANIFOLD

    K Number: K811004 · Decision May 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    64
    Review Days
    25

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    Basic Information

    Device Name
    MANIFOLD
    K Number
    K811004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    April 13, 1981
    Decision Date
    May 8, 1981
    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 American Pharmaseal Div. Ahsc

    K Number Device Name
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    K873359 AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
    K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
    K872917 JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
    K871429 ANTIMICROBIAL FOLEY CATHETER
    K871770 AMERICAN PHARMASEAL WOUND DRESSING
    K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
    K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
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