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510(k) Data Aggregation

    K Number
    K233428
    Device Name
    Easycess Aspiration Pump
    Manufacturer
    Guangzhou Easycess Medical Co., Ltd
    Date Cleared
    2023-11-03

    (23 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Easycess Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easycess Aspiration Pump is intended for general suction use in hospitals or clinics.
    Device Description
    The Easycess Aspiration Pump is mainly composed of negative pressure suction pump host and Easycess Canister(Model: DC1000). The Easycess Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Aspiration Pump operates using AC power and is designed to be portable if needed. The Aspiration Pump provides vacuum of up to 29 inHg. The pump is available in 110V and 220Vac versions. The pump is used with the available 1000ml canister / tubing set. The Easycess Aspiration Pump is provided in non-sterile; it is reusable and should be managed as a prescription device. The Easycess Canister is for single use only.
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    K Number
    K213065
    Device Name
    Distal Access Catheter
    Manufacturer
    Guangzhou Easycess Medical Co., Ltd
    Date Cleared
    2022-05-31

    (250 days)

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

    Guangzhou Easycess Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.
    Device Description
    The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively. A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories. The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter. The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.
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