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

    IDEAS OCCLUDER

    K Number: K935964 · Decision Jan 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    15
    Review Days
    387

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    Basic Information

    Device Name
    IDEAS OCCLUDER
    K Number
    K935964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ideas For Medicine, Inc.
    Date Received
    December 13, 1993
    Decision Date
    January 4, 1995
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Ideas For Medicine, Inc.

    K Number Device Name
    K961883 VERSA-CATH ARTERIAL CATHETER
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    K961716 VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
    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)
    K935023 GODAT UTERINE MANIPULATOR INJECTOR
    K880231 MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
    K872090 THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
    K872485 CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
    Search all 15 clearances from Ideas For Medicine, Inc. →