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

    3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS

    K Number: K897184 · Decision Mar 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    76

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    Basic Information

    Device Name
    3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
    K Number
    K897184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cathlab Corp.
    Date Received
    December 28, 1989
    Decision Date
    March 14, 1990
    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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    K893435 SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
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