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510(k) Data Aggregation

    K Number
    K210114
    Device Name
    Rebar Micro Catheter
    Manufacturer
    Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular
    Date Cleared
    2021-02-16

    (28 days)

    Product Code
    KRA, QJP
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
    Device Description
    The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
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