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510(k) Data Aggregation
K Number
K202919Device Name
ATS 5000 Automatic Tourniquet Instrument
Manufacturer
McEwen and Associates Consulting Ltd.
Date Cleared
2021-05-20
(233 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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
K162365Device Name
T-Cuff
Manufacturer
Terumo BCT, Inc.
Date Cleared
2017-02-16
(177 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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
K123553Device Name
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
Manufacturer
ZIMMER INC.
Date Cleared
2013-08-09
(263 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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
K112874Device Name
EZ VEIN INFLATABLE TOURNIQUET
Manufacturer
DOMINION MEDICAL DEVICES, LLC
Date Cleared
2011-10-17
(17 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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
K071140Device Name
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
Manufacturer
TOPSPINS, INC.
Date Cleared
2007-06-07
(44 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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
K050411Device Name
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
Manufacturer
ZIMMER, INC.
Date Cleared
2005-09-02
(197 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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
K012632Device Name
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
Manufacturer
MEDICAL INSTRUMENTS TECHNOLOGY, INC.
Date Cleared
2001-10-26
(74 days)
Product Code
KCY
Regulation Number
878.5910Why did this record match?
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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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