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

    V8 TRANSLUMINAL BAV CATHETER

    K Number: K123111 · Decision Jan 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    21
    Applicant Total
    5
    Review Days
    120

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    Basic Information

    Device Name
    V8 TRANSLUMINAL BAV CATHETER
    K Number
    K123111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1255
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intervalve, Inc.
    Date Received
    October 3, 2012
    Decision Date
    January 31, 2013
    Product Code
    OZT
    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
    OZT Balloon Aortic Valvuloplasty

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    Other Clearances by Intervalve, Inc.

    K Number Device Name
    K152150 V8 Balloon Aortic Valvuloplasty Catheter
    K150343 V8 Transluminal BAV Catheter
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