Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972867
    Device Name
    CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
    Manufacturer
    Date Cleared
    1997-10-24

    (81 days)

    Product Code
    Regulation Number
    864.1850
    Why did this record match?
    Product Code :

    ICX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Provide Low flow regulated negative pressure for general suction and aspiration.
    Device Description
    The Craft™ Suction Pumps have been developed to provide a smooth low volume vacuum at variable negative pressure. The device has the same technological characteristics as the predicate device. vacuum being activated by a foot operatual switch controlled by the surgeon. The range of vacuyum being variable from 0-4.50mmHg and adjustable over this range by a pre-set control. Vacuum is provided by a quiet diaphringm pump, working from a mains voltage supply (USA I IOV 60Hz). An overflow bottle provides a mensure of safety to prevent aspirated fluids being drawn into the vacuum power unit. The tran also acting us a reservoir to provide an even vacuum pressure during procedures, The foot control has an air-operated solennid, switching the main purnp unit. No electrical connections are made to the sealed foot operated control.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1