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

    DIVER C.E. CATHETER

    K Number: K050276 · Decision Mar 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    DIVER C.E. CATHETER
    K Number
    K050276
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invatec Innovative Technologies, S.R.L.
    Date Received
    February 7, 2005
    Decision Date
    March 7, 2005
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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    Other Clearances by Invatec Innovative Technologies, S.R.L.

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    K050756 SKIPPER AND SKIPPER RACE GUIDEWIRE
    K050073 MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
    K042624 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER