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

    MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER

    K Number: K880231 · Decision May 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    15
    Review Days
    133

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    Basic Information

    Device Name
    MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
    K Number
    K880231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ideas For Medicine, Inc.
    Date Received
    January 13, 1988
    Decision Date
    May 25, 1988
    Product Code
    DQT
    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
    DQT Occluder, Catheter Tip

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    Other Clearances by Ideas For Medicine, Inc.

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    K960715 PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
    K960422 PRUITT SAFETY OCCLUSION CATHETER
    K954713 DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
    K935964 IDEAS OCCLUDER
    K935023 GODAT UTERINE MANIPULATOR INJECTOR
    K872090 THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
    K872485 CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
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