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510(k) Data Aggregation

    K Number
    K202919
    Device Name
    ATS 5000 Automatic Tourniquet Instrument
    Manufacturer
    McEwen and Associates Consulting Ltd.
    Date Cleared
    2021-05-20

    (233 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATS 5000 Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations.
    Device Description
    The ATS 5000 is a non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The ATS 5000 instrument is used in conjunction with available dual port tourniquet cuffs and hoses distributed/supplied by Zimmer Biomet Inc. A cuff is applied to a patient prior to the beginning of a procedure. Connective tubing is then attached to the cuff and then plugged into the ATS 5000 connector ports. The instrument is controlled via a touchscreen user interface.
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    K Number
    K162365
    Device Name
    T-Cuff
    Manufacturer
    Terumo BCT, Inc.
    Date Cleared
    2017-02-16

    (177 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    T-Cuff is indicated for use in donor populations during apheresis procedures as an alternative method to maintain pressure on the arm and obtain venipuncture. The T-Cuff operates similar to a pneumatic tourniquet intended to partially restrict blood flow on the upper arm to result in optimal venous access during apheresis collection procedures.
    Device Description
    The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain consistent pressure on the arm and blood flow at the access site during apheresis procedures. This device is composed of 4 major components and was developed to enhance venous access during venipuncture and help donors maintain a consistent pressure on the arm during apheresis procedures. The catalog number for the T-Cuff is 71252. T-Cuff is designed to maintain a consistent pressure when applied to the donor's bicep with consistent squeezing of the inflatable bulb. During the apheresis process, the device operates in two modes: Venipuncture and Collection. The mode of operation is changed by adjusting the pressure relief valve cap. During Venipuncture mode, application of T-Cuff to the donor's upper arm prior to obtaining venipuncture allows the T-Cuff to inflate to assist with vein selection. During Collection mode, the T-Cuff maintains a consistent pressure of 20-40 mmHg (millimeter of mercury) on the donor's upper arm to help facilitate optimal blood flow during apheresis procedures. T-Cuff is a non-sterile, non-single use device. The T-Cuff is a pneumatic tourniquet used as an alternative method to maintain pressure on the arm and, aid in the facilitation of blood flow during apheresis procedures. It operates in two modes, Venipuncture and Collection. During Venipuncture mode, the T-Cuff is inflated to higher pressure (no greater than 120 mmHg) as venipuncture is performed. Once Venipuncture is complete, the device maintains a steady, lower, consistent pressure (20 - 40 mmHg) during Collection mode. The donor squeezes a rubber bulb in continuous intervals to distribute air through the system and, facilitate optimal blood flow during apheresis procedures. The T-Cuff does not contain an energy source. Primary mechanism of action is obtained through the influx of air into the system and, by a modulating pressure relief valve that maintains defined pressure ranges.
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    K Number
    K123553
    Device Name
    ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
    Manufacturer
    ZIMMER INC.
    Date Cleared
    2013-08-09

    (263 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.T.S. 4000TS Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including; Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations
    Device Description
    The Zimmer A.T.S. 4000TS Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The system consists of the A.T.S. 4000TS control unit that is coupled to the patient with the applied part (inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A. T.S. 4000TS's connector ports.
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    K Number
    K112874
    Device Name
    EZ VEIN INFLATABLE TOURNIQUET
    Manufacturer
    DOMINION MEDICAL DEVICES, LLC
    Date Cleared
    2011-10-17

    (17 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZvein™ inflatable secondary tourniquet is used in conjunction with a nonpneumatic tourniquet, to enhance the presentation of veins for access (blood draw or IV administration.)
    Device Description
    The EZ Vein inflatable secondary tourniquet is made with soft fabric and flexible plastic to form an inflatable bladder. The integral Velcro attachment strips secure the EZVein around an appendage in the same way as would a blood pressure cuff. Dimensions have been chosen to wrap around most anyone's arm, but an extension is included to allow the EZVein to work on lower limbs or with large arms. The Vein Access Window allows the health care professional to position the EZVein over the target vein for access for IV drip, blood draw or injection. The EZVein cuff is applied after the initial conventional non-inflatable tourniquet (such as latex tubing) is applied. The initial tourniquet, as is conventional, blocks the return of venous blood through the major veins to the heart, but the application of the EZVein inflatable cuff helps move the blood in deep tissues into the veins to help them to distend for easier visualization and access. This may aid the medic desiring venous access to more accurately and rapidly achieve the desired aim.
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    K Number
    K071140
    Device Name
    MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
    Manufacturer
    TOPSPINS, INC.
    Date Cleared
    2007-06-07

    (44 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.
    Device Description
    Not Found
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    K Number
    K050411
    Device Name
    ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
    Manufacturer
    ZIMMER, INC.
    Date Cleared
    2005-09-02

    (197 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.T.S. 3000 Automatic Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations
    Device Description
    The Zimmer A. T.S. 3000 Automatic Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The system consists of the A.T.S. 3000 control unit that is coupled to the patient with the applied part (inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A.T.S. 3000's connector ports.
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    K Number
    K012632
    Device Name
    TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
    Manufacturer
    MEDICAL INSTRUMENTS TECHNOLOGY, INC.
    Date Cleared
    2001-10-26

    (74 days)

    Product Code
    KCY
    Regulation Number
    878.5910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.
    Device Description
    Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to restrict the blood flow in the limb during surgery.
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