FDA 510(k) Applications for Medical Device Product Code: KTI (Bronchoscope Accessory)

FDA 510(k) Applications for Medical Device Product Code "KTI"
(Bronchoscope Accessory)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K090660	ACCLARENT, INC.	AIRWAY BALLOON CATHETER INFLATION DEVICE	06/12/2009
K110218	ACCLARENT, INC.	INSPIRA AIR BALLOON DILATION SYSTEM	03/31/2011
K082174	ASTHMATX, INC.	Y-ADAPTER	10/20/2008
K023337	BOSTON SCIENTIFIC CORP.	CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350	11/18/2002
K020765	BOSTON SCIENTIFIC CORP.	MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210	04/05/2002
K170759	Boston Scientific Corporation	CRE Pulmonary Balloon Dilatation Catheter	06/23/2017
K150951	Bryan Medical , Inc.	aeris Balloon Dialation Catheter	06/25/2015
K211894	DISA Medinotec	Trachealator	11/24/2021
K222187	Dongguan TT Medical, Inc.	Multistage Balloon Dilatation Catheter	03/01/2023
K230280	GA Health Company Limited	ANDORATE« Suction Valve and ANDORATE« Biopsy Valve	05/11/2023
K153484	INTUIT MEDICAL PRODUCTS, LLC	Dillard Airway Dilatation System	07/27/2016
K151522	MEDIVATORS, INC.	DEFENDO Bronchoscopy Suction Valve	09/17/2015
K161392	MERIT MEDICAL SYSTEMS, INC.	Elation Pulmonary Balloon Dilation	09/01/2016
K213434	Merit Medical Systems, Inc.	Elation Pulmonary Balloon Dilation Catheter	03/08/2022
K213060	Micro-Tech (Nanjing) Co., Ltd.	AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle	07/20/2022
K190239	Olympus Medical Systems Corp.	Single Use Aspiration Needle	12/10/2019
K171232	Olympus Surgical Technologies America	PeriView FLEX	09/21/2017
K181193	Olympus Surgical Technologies America	PeriView FLEX	07/03/2018
K163469	Olympus Surgical Technologies America	ViziShot 2 FLEX	04/06/2017
K193517	Olympus Surgical Technologies America	ViziShot 2 FLEX	03/18/2020
K230778	Praxis Medical, LLC	EndoCore	09/25/2023
K221206	Serpex Medical, Inc.	Compass Steerable Needle	08/25/2022
K152922	SPIRATION, INC.	ViziShot FLEX	02/19/2016

FDA 510(k) Applications for Medical Device Product Code "KTI" (Bronchoscope Accessory)

FDA 510(k) Applications for Medical Device Product Code "KTI"
(Bronchoscope Accessory)