BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇷 Türkiye

    Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters

    K Number: K143604 · Decision Jun 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    2
    Review Days
    189

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    Basic Information

    Device Name
    Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
    K Number
    K143604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
    Date Received
    December 18, 2014
    Decision Date
    June 25, 2015
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S

    K Number Device Name
    K141529 ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER