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510(k) Data Aggregation

    K Number
    K220507
    Device Name
    3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
    Manufacturer
    Date Cleared
    2022-05-23

    (90 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Product Code :

    PZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3MTM Curos™ Tamper-Evident Device: The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device. 3MTM Curos™ Tamper-Evident Device, Large: The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device provides visual indication to suspect tampering. This is not a tamper-proof device.
    Device Description
    The 3M™ Curos™ Tamper-Evident Device provides visual indication to suspect tampering with or attempted removal of the device for reasons other than delivering prescribed medical treatment. The Tamper-Evident Device can be used on any type of vascular access device to cover needleless connectors and the Y-sites on IV tubing [with or without disinfecting caps]. The device material is transparent allowing for visualization of the connector(s) inside, and the tamper-evident strap is green allowing for easy visualization and assessment. The 3M™ Curos™ Tamper-Evident Device is also provided in a larger size to accommodate larger needleless connector combinations including the Y-sites on IV tubing [with or without disinfecting caps] and infusing connections.
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    K Number
    K191195
    Device Name
    PiccGuard
    Manufacturer
    Date Cleared
    2020-01-03

    (245 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Product Code :

    PZW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PICCGuard device is indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.
    Device Description
    The PICCGuard is a two-piece plastic housing with locking barb that inserts through a hole in the bottom housing. After inserting the shaft of the catheter and Luer hub with needleless connector attached, the two halves slide together, and the barb is pushed through the hole in the bottom housing. Once the barb is inserted, the housing is locked. When a healthcare provider needs intravenous access, medical scissors can be used to disconnect the lid from the locked portion. The PICCGuard is then removed giving access to the needleless connector, and the health care provider can administer medications per normal routine.
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