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

    ENTERPRISE

    K Number: K935998 · Decision Nov 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    2
    Review Days
    702

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    Basic Information

    Device Name
    ENTERPRISE
    K Number
    K935998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Camp Intl., Inc.
    Date Received
    December 15, 1993
    Decision Date
    November 17, 1995
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Camp Intl., Inc.

    K Number Device Name
    K940238 TUMBLE FORMS JUNIOR TRISTANDER