BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET

    K Number: K925533 · Decision Jan 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
    K Number
    K925533
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Angeion Corp.
    Date Received
    November 2, 1992
    Decision Date
    January 12, 1993
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GBX Catheter, Irrigation

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