BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP

    K Number: K894794 · Decision Nov 21, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    116

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    Basic Information

    Device Name
    AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP
    K Number
    K894794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5955
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vitaid, Ltd.
    Date Received
    July 28, 1989
    Decision Date
    November 21, 1989
    Product Code
    KPM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPM Shunt, Peritoneal

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    Other Clearances by Vitaid, Ltd.

    K Number Device Name
    K050803 PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
    K932647 WIRE REINFORCED ENDOTRACHEAL TUBE
    K901738 SELFCATH
    K894883 PHYCON ALL SILICONE BALLOON CATHETER
    K894669 LASER SHIELDING TUBE
    K894337 UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM