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510(k) Data Aggregation

    K Number
    K233069
    Device Name
    Removal System Large Bore 60 cc Syringe
    Manufacturer
    Inari Medical, Inc.
    Date Cleared
    2024-03-26

    (182 days)

    Product Code
    PUR
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    PUR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Removal System Large Bore 60 cc Syringe is used with the Removal Catheters to inject fluids into or withdraw fluids and/or tissues from the body. It can be used for aspiration removal of fluid and/or tissue in the form of abscess fluid, infected materials, etc.
    Device Description
    The Removal System Large Bore 60 cc Syringe is a general piston syringe constructed using a barrel, plunger, plunger seal, and large bore Toomey tip adapter that acts as a quick-release connector. The quick-release connector is compatible with the Removal System Catheters' sideport connector to establish an airtight seal. The twist-to-lock plunger with barrel tabs maintains the retracted position of the plunger.
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    K Number
    K230999
    Device Name
    INT Vacuum Locking Syringe
    Manufacturer
    Shanghai Kindly Medical Instruments Co.,Ltd
    Date Cleared
    2024-02-23

    (322 days)

    Product Code
    PUR
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    PUR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)
    Device Description
    The INT Vacuum Locking Syringe is used to inject or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g., thrombus, abscess fluid, bile, urine etc.). The Syringe consists of graduation lines, zero line, luer connector, nozzle lumen, seals, barrel, plunger, push-button, barrel flanges, locking column, locking piece and fiducial line. When the Syringe is used, it can be divided into two situations: normal suction in normal state and vacuum suction in locked state. Vacuum Locking Syringe is placed in a soft blister box which is composed of Tyvek 2FS and PE. The proposed device is sterilized by EO and intended for single use. The packaging form is sealed packaging and guarantees that the product is sterile until opening. The packaging can ensure the sterilized finished device during its shelf life of 3 years.
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    K Number
    K163597
    Device Name
    VacLok AT Vacuum Syringe
    Manufacturer
    Merit Medical Systems, Inc.
    Date Cleared
    2017-07-27

    (218 days)

    Product Code
    PUR
    Regulation Number
    880.5860
    Why did this record match?
    Product Code :

    PUR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).
    Device Description
    The VacLok™ AT Vacuum Syringe is a general piston syringe constructed using a barrel, plunger, piston seal, and locking mechanism. It is designed to lock in any position along the length of the barrel with the capability of holding a vacuum when the cam locking mechanism is engaged.
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