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

    BOOMERANG WIRE

    K Number: K061075 · Decision Sep 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    7
    Review Days
    137

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    Basic Information

    Device Name
    BOOMERANG WIRE
    K Number
    K061075
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiva Medical, Inc.
    Date Received
    April 17, 2006
    Decision Date
    September 1, 2006
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Cardiva Medical, Inc.

    K Number Device Name
    K130124 CATALYST II AND III
    K082930 CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
    K072297 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
    K070485 BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
    K051817 BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
    K041486 VASOSTASIS VASCULAR CLOSURE SYSTEM