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 |
| K241679 | Alton (Shanghai) Medical Instruments Co. Ltd | Disposable Cytology Brush (AF series) | 03/04/2025 |
| 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 |
| K231818 | M/s Meril Life Sciences Pvt. Ltd. | METICÖ- Airway Balloon Catheter | 11/15/2023 |
| 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 |
| K250263 | Olympus Medical Systems Corp. | Disposable Grasping Forceps FG-52D/FG-54D | 03/31/2025 |
| 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 |
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