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510(k) Data Aggregation

    K Number
    K240460
    Device Name
    FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
    Manufacturer
    Date Cleared
    2024-06-13

    (118 days)

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

    FMD Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K212268
    Device Name
    FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
    Manufacturer
    Date Cleared
    2022-05-27

    (311 days)

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

    FMD Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use of the FMD Peripheral Guide Wires F-14 and F-18 : The FMD Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only. The indications for use of the FMD Guide Wire Extension F-14 EXT : The FMD Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
    Device Description
    The FMD Peripheral Guide Wires F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The guide wires are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190cm to 300cm. The F-14 and F-18 guide wires with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension F-14 EXT, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless-steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating. All wires are available in a straight tip configuration. The FMD Guide Wire Extension F-14 EXT is composed of a stainless steel core wire coated with PTFE. It has an outer diameter of 0.014" (0.36 mm) and a length of 165cm. Its distal end contains a connecting hypotube that is compatible with guide wires less than 300cm of both the F-14 and F-18 series. Attachment of the FMD Guide Wire Extension F-14 EXT to FMD's extendable guide wire creates an extended guide wire that can be used to exchange out a percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the artery. When the exchange is complete, the FMD Guide Wire Extension F-14 EXT can be detached, and the original guide wire can be used in a conventional manner.
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