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510(k) Data Aggregation

    K Number
    K232647
    Device Name
    Microcatheter
    Manufacturer
    Date Cleared
    2023-09-29

    (29 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surmodics. Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures. Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
    Device Description
    The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection. The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the distal end. The catheter is available in working lengths of 135 cm and 150 cm to facilitate access to various target sites.
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