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510(k) Data Aggregation

    K Number
    K182553
    Device Name
    Inno-Pathwire
    Date Cleared
    2019-03-11

    (175 days)

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

    Suzhou Innomed Medical Device Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
    Device Description
    The Inno-Pathwire is a steerable guidewire available in a diameter of 0.014" (0.36 mm) and an effective length of 190 cm. The distal tip is shapeable. Before use, the tip can be shaped "J". The wire construction includes a stainless steel proximal shaft and a distal super-elastic nitinol shaft for flexibility and performance. The two shafts are connected by a super-elastic nitinol hypotube. The distal shaft is soldered with the tip coil or the tip coil and proximal coil both. For IW-14-190-EXS model, the distal shaft is soldered to the tip coil only but for IW-14-190-STS and IW-14-190-MDS, their distal shafts are soldered to the tip coil and proximal coil both. The tip coil is visible under Xray to assist the physician with the movement of the guidewire. The distal segment of the guidewire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guidewire movement within the catheter and arteries. The proximal end of the guidewire is coated with PTFE coating which reduces friction of the wire within a catheter. The guidewire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire for twisting and controlling the guidewire. The guidewires are packaged within a cardboard box which contains five individual guidewires.
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    K Number
    K172187
    Device Name
    Inno-Hydrowire
    Date Cleared
    2018-04-11

    (265 days)

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

    Suzhou Innomed Medical Device Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.
    Device Description
    The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The Hydrowires are packaged within a cardboard box which contains five individual guidewires.
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