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

    OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302

    K Number: K022145 · Decision Jan 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    32
    Review Days
    196

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    Basic Information

    Device Name
    OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
    K Number
    K022145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    LeMaitre Vascular, Inc.
    Date Received
    July 2, 2002
    Decision Date
    January 14, 2003
    Product Code
    DXE
    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
    DXE Catheter, Embolectomy

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