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510(k) Data Aggregation

    K Number
    K173563
    Device Name
    ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
    Manufacturer
    TZ Medical Inc
    Date Cleared
    2018-01-10

    (54 days)

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

    TZ Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).
    Device Description
    The TZ Medial ARC Adjustable Radial Cuff "ARC" compression device is used at the end of a Transradial catheterization procedures to provide hemostasis of the radial artery at the access site. The ridged brace designed radial compression device consisting of a rigid polycarbonate "C" shaped brace, a flexible strap containing a PVC backing, hook and loop fasteners, and two buckles which attach to the ends of the brace, a collapsible bubble fixed to an adjustable slider with an air fill tube and universal luer lock, as well as back pad opposite of the bubble for patient comfort. Each device also includes a standard 20cc male luer locking syringe. The Cuff is positioned around the patient's wrist and secured in place by fastening and tightening the Back Hook and Strap Assembly. As the introducer sheath is removed from the patient's wrist, pressure is applied to the access site by inflating the compression bubble of the ARC device. The bubble is inflated when air is injected through a luer lock air injection port which assures the desired air volume/pressure remains in the compression bubble. The volume/pressure in the bubble can be titrated by the physician to meet the hemodynamic needs of the patient by increasing or decreasing the volume in the ARC device bubble. The ARC devices is intended for a single use only with a Functional life is less than 24 hours. This device is individually packaged and sterilized by ethylene oxide gas.
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    K Number
    K163322
    Device Name
    TZ SKULL PIN Adult
    Manufacturer
    TZ MEDICAL INC
    Date Cleared
    2017-02-23

    (90 days)

    Product Code
    HBL
    Regulation Number
    882.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    TZ MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
    Device Description
    The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy. The TZ Skull Pin is used during neurosurgical procedures to immobilize the head in reference to the torso and to provide cervical immobilization.
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