FDA 510(k) Applications for Medical Device Product Code "GCA"
(Catheter, Biliary, Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K210660 | Anrei Medical (Hangzhou) Co., Ltd. | Stone Retrieval Balloon Catheter | 04/27/2021 |
| K212582 | Boston Scientific Corporation | SpyGlass Discover Balloon Dilation Catheter | 05/06/2022 |
| K173414 | Cook Incorporated | Advance Biliary Balloon Catheter | 06/22/2018 |
| K980917 | FORTUNE MEDICAL INSTRUMENT CORP. | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR | 05/27/1998 |
| K200173 | Hangzhou AGS MedTech Co., Ltd. | Stone Retrieval Balloon | 05/01/2020 |
| K232752 | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL- | 02/26/2024 |
| K011018 | TAUT, INC. | TAUT BALLOON CATHETER, MODEL 50640 | 06/22/2001 |
| K193344 | Wilson-Cook Medical Inc. | Tri-Ex Extraction Balloon with Multiple Sizing | 12/13/2019 |
| K200247 | Wilson-Cook Medical, Inc | Fusion Quattro Extraction Balloon | 02/27/2020 |
| K173659 | Wilson-Cook Medical, Inc | Howell D.A.S.H Extraction Balloon with Multiple Sizing | 07/06/2018 |
| K170292 | WILSON-COOK MEDICAL, INC | Tri-Ex Extraction Balloon With Multiple Sizing | 09/20/2017 |
| K063677 | WILSON-COOK MEDICAL, INC. | FUSION QUATTRO EXTRACTION BALLOON XL | 01/05/2007 |
| K040129 | WILSON-COOK MEDICAL, INC. | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING | 02/27/2004 |
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