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

    MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,

    K Number: K053460 · Decision Jan 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    145
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
    K Number
    K053460
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fox Hollow Technologies
    Date Received
    December 13, 2005
    Decision Date
    January 13, 2006
    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 Fox Hollow Technologies

    K Number Device Name
    K071432 SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
    K071826 THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910
    K043553 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
    K024243 REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406