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

    OCCLUSION CATHETER

    K Number: K811276 · Decision Jun 30, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    5
    Review Days
    53

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    Basic Information

    Device Name
    OCCLUSION CATHETER
    K Number
    K811276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bionomy, Inc.
    Date Received
    May 8, 1981
    Decision Date
    June 30, 1981
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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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
    K832023 EMBOLECTOMY CATHETER
    K812111 PRUITT ARTERIAL OCCLUSION CHOLANG. CATH