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

    PRESSURE BARRIER KIT CAT. NO. PBK-3

    K Number: K873802 · Decision Nov 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    20
    Review Days
    49

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    Basic Information

    Device Name
    PRESSURE BARRIER KIT CAT. NO. PBK-3
    K Number
    K873802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Omni Medical, Inc.
    Date Received
    September 18, 1987
    Decision Date
    November 6, 1987
    Product Code
    DXS
    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
    DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

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    Other Clearances by American Omni Medical, Inc.

    K Number Device Name
    K922781 FLOW CONROL VALVE
    K922356 FLOW CONTROL VALVE, CAT. NO. ACV-38
    K900672 PREBYPASS FILTER, CAT. NO. FPB-5
    K884893 CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
    K884640 CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
    K873316 BUBBLE TRAP-FILTER CAT. NO B180F37
    K875080 AIR VENT LINE CAT. NO. AVL-36
    K873610 PEDIATRIC BUBBLE TRAP CAT. NO. B-100
    K873488 SILENT GUARD CAT. NO. SG-10
    K871632 NASOGASTRIC VOICETUBE
    Search all 20 clearances from American Omni Medical, Inc. →