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

    EMBOLECTOMY CATHETER

    K Number: K832023 · Decision Aug 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    5
    Review Days
    79

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    Basic Information

    Device Name
    EMBOLECTOMY CATHETER
    K Number
    K832023
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bionomy, Inc.
    Date Received
    June 13, 1983
    Decision Date
    August 31, 1983
    Product Code
    DXE
    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
    DXE Catheter, Embolectomy

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    Other Clearances by Bionomy, Inc.

    K Number Device Name
    K851101 BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET
    K844094 PRUITT IRRIGATION AND OCCLUSION CATHETER
    K812111 PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
    K811276 OCCLUSION CATHETER