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

    CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

    K Number: K872485 · Decision Aug 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    15
    Review Days
    51

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    Basic Information

    Device Name
    CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
    K Number
    K872485
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ideas For Medicine, Inc.
    Date Received
    June 22, 1987
    Decision Date
    August 12, 1987
    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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