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510(k) Data Aggregation

    K Number
    K061188
    Device Name
    SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
    Manufacturer
    FOXHOLLOW TECHNOLOGIES, INC.
    Date Cleared
    2006-10-23

    (178 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOXHOLLOW TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.
    Device Description
    The SilverHawk™ Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk™ Peripheral Catheter and SilverHawk™ Cutter Driver. The SilverHawk™ Peripheral Plaque Excision System will be provided sterile for singleuse. The catheter will be sterilized by Ethylene Oxide (ANSVAAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 106, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1. The SilverHawk™ Peripheral Plaque Excision System with the additional clinical contraindication statement is identical in material of construction, overall design, intended use, and safety and efficacy to the predicate device.
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    K Number
    K061063
    Device Name
    MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
    Manufacturer
    FOXHOLLOW TECHNOLOGIES, INC.
    Date Cleared
    2006-05-18

    (31 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOXHOLLOW TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: The SilverHawk™ Peripheral Plaque Excision System is intended for use in atherectorny of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.
    Device Description
    The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System is provided sterile for single-use.
    Ask a Question

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