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

    AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*

    K Number: K875090 · Decision Feb 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    218
    Review Days
    82

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    Basic Information

    Device Name
    AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
    K Number
    K875090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    December 9, 1987
    Decision Date
    February 29, 1988
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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