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

    IMPCO DISPOSABLE AORTIC PUNCH

    K Number: K780247 · Decision Feb 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    313
    Registration Numbers
    313
    Same Product Code
    70
    Applicant Total
    10
    Review Days
    14

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    Basic Information

    Device Name
    IMPCO DISPOSABLE AORTIC PUNCH
    K Number
    K780247
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Thoratec Laboratories Corp.
    Date Received
    February 13, 1978
    Decision Date
    February 27, 1978
    Product Code
    DWS
    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
    DWS Instruments, Surgical, Cardiovascular

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