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

    SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

    K Number: K893680 · Decision Aug 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    8
    Review Days
    77

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    Basic Information

    Device Name
    SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.
    K Number
    K893680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cathlab Corp.
    Date Received
    May 16, 1989
    Decision Date
    August 1, 1989
    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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    K897184 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS
    K893435 SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
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