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

    AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

    K Number: K083919 · Decision Mar 13, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    7
    Review Days
    72

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    Basic Information

    Device Name
    AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
    K Number
    K083919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invatec Innovative Technologies, S.R.L.
    Date Received
    December 31, 2008
    Decision Date
    March 13, 2009
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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

    K Number Device Name
    K052791 MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
    K051917 DIVER C.E. CATHETER
    K050756 SKIPPER AND SKIPPER RACE GUIDEWIRE
    K050276 DIVER C.E. CATHETER
    K050073 MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
    K042624 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER