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

    AIR VENT LINE CAT. NO. AVL-36

    K Number: K875080 · Decision Feb 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    20
    Review Days
    82

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    Basic Information

    Device Name
    AIR VENT LINE CAT. NO. AVL-36
    K Number
    K875080
    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
    December 9, 1987
    Decision Date
    February 29, 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.

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    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
    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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