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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?
Applicant Name (Manufacturer) :
McEwen and Associates Consulting Ltd.
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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