FDA 510(k) Applications for Medical Device Product Code "KCY"
(Tourniquet, Pneumatic)

FDA 510(k) Number Applicant Device Name Decision Date
K112874 DOMINION MEDICAL DEVICES, LLC EZ VEIN INFLATABLE TOURNIQUET 10/17/2011
K202919 McEwen and Associates Consulting Ltd. ATS 5000 Automatic Tourniquet Instrument 05/20/2021
K012632 MEDICAL INSTRUMENTS TECHNOLOGY, INC. TOURNIQUET CUFF; PNEUMATIC TOURNIQUET 10/26/2001
K955552 SMITH & NEPHEW RICHARDS, INC. EXPRESSAIRE TORUNIQUET SYSTEM 01/05/1996
K162365 Terumo BCT, Inc. T-Cuff 02/16/2017
K071140 TOPSPINS, INC. MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 06/07/2007
K123553 ZIMMER INC. ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM 08/09/2013
K050411 ZIMMER, INC. ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 09/02/2005


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