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

    SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM

    K Number: K022640 · Decision Dec 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    10
    Review Days
    116

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    Basic Information

    Device Name
    SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
    K Number
    K022640
    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
    August 8, 2002
    Decision Date
    December 2, 2002
    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.

    K Number Device Name
    K082199 SPIRALFUSE PERIPHERAL INFUSION SYSTEM
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    K033997 SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
    K032261 Trellis Reserve Infusion System
    K023514 TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)
    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)
    K003570 BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755