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

    SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110

    K Number: K033997 · Decision Feb 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    10
    Review Days
    42

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    Basic Information

    Device Name
    SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
    K Number
    K033997
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bacchus Vascular, Inc.
    Date Received
    December 24, 2003
    Decision Date
    February 4, 2004
    Product Code
    MCW
    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
    MCW Catheter, Peripheral, Atherectomy

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    Other Clearances by Bacchus Vascular, Inc.

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    K022640 SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
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    K021958 TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H
    K013635 TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
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