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

    Wedge Microcatheter

    K Number: K172014 · Decision Apr 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    271
    Registration Numbers
    272
    Same Product Code
    880
    Applicant Total
    2
    Review Days
    276

    Basic Information

    Device Name
    Wedge Microcatheter
    K Number
    K172014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Vention, Inc.
    Date Received
    July 3, 2017
    Decision Date
    April 5, 2018
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.

    Primum Hydrophilic Guiding Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CPS Locator 3D Plus Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAT CenterFlow Molding Balloon Catheter (IN20-00313)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FlexiGo 3D Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dorado™ PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE® Tri-Lobe Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Micro Vention, Inc.

    K Number Device Name
    K151358 AZUR CX Detachable 35 Coils