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

    BUBBLE TRAP-FILTER CAT. NO B180F37

    K Number: K873316 · Decision Jul 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    20
    Review Days
    330

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    Basic Information

    Device Name
    BUBBLE TRAP-FILTER CAT. NO B180F37
    K Number
    K873316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Omni Medical, Inc.
    Date Received
    August 19, 1987
    Decision Date
    July 14, 1988
    Product Code
    DTM
    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
    DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

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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
    K875080 AIR VENT LINE CAT. NO. AVL-36
    K873802 PRESSURE BARRIER KIT CAT. NO. PBK-3
    K873610 PEDIATRIC BUBBLE TRAP CAT. NO. B-100
    K873488 SILENT GUARD CAT. NO. SG-10
    K871632 NASOGASTRIC VOICETUBE
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