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510(k) Data Aggregation

    K Number
    K191827
    Device Name
    Sunmed Disposable Angio-Closure Pads
    Date Cleared
    2020-03-16

    (252 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sunny Medical Device (Shenzhen) Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sunmed disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.
    Device Description
    disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.
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    K Number
    K160190
    Device Name
    Sunmed Control Syringes
    Date Cleared
    2016-11-10

    (288 days)

    Product Code
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sunny Medical Device (Shenzhen) Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures.
    Device Description
    The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use. The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type. The volume of two type control syringes that to be offered in 10ml, 12ml. The sunmed™ Control Syringes are available with rotating male luer and fixed male luer. The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization.
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