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510(k) Data Aggregation

    K Number
    K003398
    Device Name
    WIRECLIP TORQUER
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY
    Date Cleared
    2000-12-01

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993648
    Device Name
    ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY
    Date Cleared
    1999-11-24

    (26 days)

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

    BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The peripheral Rotablator system is intended for percutaneous use in peripheral vessels in patients with occlusive atherosclerotic disease who are acceptable candidates for bypass graft surgery or percutaneous transluminal angioplasty.
    Device Description
    The Rotablator® Rotational Angioplasty system uses a high speed, rotating, diamondcoated burr to ablate occlusive material and restore luminal patency. The burr spins at 140.000-190.000 RPM and ablates material into very fine particles that are carried distally and removed via the reticuloendothelial system. The Rotablator System with Exchangeable Catheter comprises four main components: advancer, catheter with diamond-coated burr, console and foot pedal, and guide wire.
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