FDA 510(k) Applications for Medical Device Product Code: BSK (Cuff, Tracheal Tube, Inflatable)

FDA 510(k) Applications for Medical Device Product Code "BSK"
(Cuff, Tracheal Tube, Inflatable)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K092733	ARM MEDICAL DEVICES, INC.	PYTON	02/26/2010
K220854	AW Technologies ApS	TrachCuff Cuff Controller	04/14/2023
K192611	Biovo Technologies Ltd.	Cuffix	08/13/2020
K202874	Covidien llc	Puritan Bennett Cuff Pressure Manager	01/09/2021
K150893	HAMILTON MEDICAL AG	IntelliCuff	01/29/2016
K180991	Hospitech Respiration Ltd.	AG 100s	10/12/2018
K122721	HOSPITECH RESPIRATION LTD.	AG GUFFILL	05/03/2013
K221477	Hospitech Respiration Ltd.	AG100s	12/29/2022
K150157	HOSPITECH RESPIRATION LTD.	AnapnoGuard 100 Respiratory Guard System	02/16/2016
K113644	INSTRUMENTATION INDUSTRIES, INC.	PILOT TUBE REPAIR KIT	01/26/2012
K973755	INSTRUMENTATION INDUSTRIES, INC.	PILOT TUBE REPAIR KIT	12/17/1997
K102704	JOAN SPIEGEL, MD	EASY CUFF	03/10/2011
K191858	Kal-Med LLC	Pylant Monitor	02/24/2020
K112915	SPIRITUS TECHNOLOGIES LLC	SPIRTIUS CUFF INFLATION SYRINGE	05/25/2012
K081805	SUNMED	CUFFALERT	11/14/2008
K142103	Teleflex Medical, Inc.	CUFF PILOT, SURE SEAL	05/08/2015
K182548	Tianjin Medis Medical Device Co., Ltd.	Accucuff Cuff Pressure Indicator	01/25/2019
K152778	TRACOE MEDICAL GMBH	TRACOE Cuff Pressure Monitor	12/21/2016
K152865	TRACOE MEDICAL GMBH	TRACOE smart Cuff Manager	09/27/2016
K110631	VENNER MEDICAL (SINGAPORE) PTE LTD	VENNER TRACHEAL SEAL MONITOR	07/28/2011
K102674	VENTLAB CORP.	CUFF SENTRY	07/22/2011
K173914	VORTRAN Medical Technology 1, Inc.	VORTRAN Cuff Inflator (VCI)	05/25/2018