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510(k) Data Aggregation

    K Number
    K210037
    Device Name
    Pluski Safe 1 Safety IV Catheter
    Date Cleared
    2022-03-25

    (443 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediplus (India) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pluski Safe 1 Safety IV Catheter is Passive anti-needle stick device for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14-22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
    Device Description
    Pluski Safe 1 Safety I.V. Catheter is a medical device used for inserting a catient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. The device is equipped with a safety feature intended to prevent needle stick injuries. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids and have hence been potentially contaminated with infectious agents. The device contains different parts like Needle cover, Catheter holder, body, Cross clip safety & filterHub cover. Devices are available in winged and non-winged version. These devices are sold in sterile form & are single use devices.
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